Dupuytren's ContracturePhase 3POINT XNCT01229436
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
A Phase 3 study testing Xiapex in people with Dupuytren's Contracture, run by Pfizer at 28 sites in 8 countries.
Trial summary
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dupuytren's Contracture
- What is being tested?
- Xiapex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 28 sitesin 8 countries
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Who cannot join
- Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Germany6 sites
Pfizer Investigational Site
Bad Neustadt an der Saale, 97616
Pfizer Investigational Site
Berlin, 10627
Pfizer Investigational Site
Bonn, 53123
Pfizer Investigational Site
Münster, 48149
Pfizer Investigational Site
Nuremberg, 90471
Pfizer Investigational Site
Tübingen, 72076
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Barcelona, 08022
Pfizer Investigational Site
Elche, Alicante, 03203
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona/ Spain, 08907
Pfizer Investigational Site
Málaga, Málaga, 29010
France4 sites
Pfizer Investigational Site
Montpellier, 34295
Pfizer Investigational Site
Nice, 06000
Pfizer Investigational Site
Paris, 75016
Pfizer Investigational Site
Paris, Cedex 15 75908
United Kingdom4 sites
Pfizer Investigational Site
Derby, DE22 3NE
Pfizer Investigational Site
Glasgow, G4 0SF
Pfizer Investigational Site
Norwich, NR4 7UY
Pfizer Investigational Site
Southampton, SO16 6YD
Italy3 sites
Pfizer Investigational Site
Modena, 41124
Pfizer Investigational Site
Savona, 17100
Pfizer Investigational Site
Sesto San Giovanni, Milano, 20099
Sweden3 sites
Pfizer Investigational Site
Malmö, SE-205 02
Pfizer Investigational Site
Stockholm, SE 118 83
Pfizer Investigational Site
Uppsala, 751 85
Denmark2 sites
Pfizer Investigational Site
Copenhagen, 1402 K
Pfizer Investigational Site
Silkeborg, 8600
About this study
Official title: Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
- Conditions
- Dupuytren's Contracture
- Being tested
- Xiapex
- Keywords
- Dupuytren's, treatment, injection, recovery, health care resources
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XiapexDrug
Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
| Study group | Role | What they receive |
|---|---|---|
| Xiapex Injection | Experimental | Not described Receives: Drug: Xiapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Passive Extension Deficit (TPED) at Baseline for First Injection
TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Baseline for first injection
Total Passive Extension Deficit (TPED) at Baseline for Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Baseline for second injection
Total Passive Extension Deficit (TPED) at Baseline for Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Baseline for third injection
Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Baseline for fourth injection
Total Passive Extension Deficit (TPED) at Day 1 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 1 after first injection
Total Passive Extension Deficit (TPED) at Day 7 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 7 after first injection
Total Passive Extension Deficit (TPED) at Day 30 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 30 after first injection
Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 1 after second injection
Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 7 after second injection
Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 30 after second injection
Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 1 after third injection
Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 7 after third injection
Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 30 after third injection
Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 1 after fourth injection
Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 7 after fourth injection
Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 30 after fourth injection
Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 90 after last injection
Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Day 180 after last injection
Secondary outcomes (14)
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Measured: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection
TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Measured: Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection
PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Measured: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Measured: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Participant Global Assessment of Treatment Satisfaction and Disease Severity
Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.
Measured: Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Physician Global Assessment of Treatment Satisfaction and Disease Severity
Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.
Measured: Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Number of Participants With Type of Concomitant Pain Medication Used
Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.
Measured: Screening up to Day 180 after last injection
Number of Days of Concomitant Pain Medication Usage
Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.
Measured: Screening up to Day 180 after last injection
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire
Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).
Measured: C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30
Time to Recovery
Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.
Measured: Up to Day 30 after first, second and third injection
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score
URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.
Measured: Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.
Measured: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.
Measured: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.
Measured: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229436
- Sponsor's protocol ID
- B1531002
- Acronym
- POINT X
- Status last verified
- Jan 2014
- First submitted
- 26 Oct 2010
- Last updated
- 17 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.
PubMed 24470559
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)
- ClinicalTrials.gov ID
- NCT01229436
- Acronym / sponsor ID
- POINT X / B1531002
- Conditions
- Dupuytren's Contracture
- Keywords
- Dupuytren's, treatment, injection, recovery, health care resources
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xiapex Injection | Experimental | Drug: Xiapex |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Key exclusion criteria (3 listed)
- Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XiapexXiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol | Drug | Xiapex Injection |
Primary outcome
Total Passive Extension Deficit (TPED) at Baseline for First Injection
Time frame: Baseline for first injection
TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Second Injection
Time frame: Baseline for second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Third Injection
Time frame: Baseline for third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
Time frame: Baseline for fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After First Injection
Time frame: Day 1 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After First Injection
Time frame: Day 7 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After First Injection
Time frame: Day 30 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
Time frame: Day 1 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
Time frame: Day 7 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
Time frame: Day 30 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
Time frame: Day 1 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
Time frame: Day 7 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
Time frame: Day 30 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
Time frame: Day 1 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
Time frame: Day 7 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
Time frame: Day 30 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
Time frame: Day 90 after last injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
Time frame: Day 180 after last injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
14 secondary outcomes
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection
Time frame: Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Participant Global Assessment of Treatment Satisfaction and Disease Severity
Time frame: Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Physician Global Assessment of Treatment Satisfaction and Disease Severity
Time frame: Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Number of Participants With Type of Concomitant Pain Medication Used
Time frame: Screening up to Day 180 after last injection
Number of Days of Concomitant Pain Medication Usage
Time frame: Screening up to Day 180 after last injection
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire
Time frame: C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30
Time to Recovery
Time frame: Up to Day 30 after first, second and third injection
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24470559Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xiapex in people with Dupuytren's Contracture, run by Pfizer at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Spain, France, United Kingdom, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Passive Extension Deficit (TPED) at Baseline for First Injection (time frame: Baseline for first injection). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01229436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.