Surgical AdhesionsPhase 2PHSU02NCT01022242
Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
A Phase 2 study testing PXL01 in people with Surgical Adhesions, run by Pergamum AB at 15 sites in 3 countries.
Trial summary
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Surgical Adhesions
- What is being tested?
- PXL01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Dec 2009to Feb 2013
- Phase
- Phase 2
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
- Open flexor tendon injury sutured within 14 days after trauma
- 12-75 years of age
- Signed informed consent prior to any study related procedures
Who cannot join
- Treatment with any investigational product within 4 weeks of study entry
- Patients previously included in the study
- Thumbs with complete or partial division of flexor pollicis longus (FPL)
- Concomitant fracture(s) requiring immobilisation
- Injuries with associated soft tissue loss
- Severe crush injury
Show all 25Show fewer
- Palmar plate injury requiring immobilisation
- Devascularisation/requirement of vascular repair
- Joint injuries
- Bilateral injuries
- Previous flexor tendon surgery in the digit, which is to be treated with IMP
- Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
- Compliance with mobilisation protocol not expected
- Alcohol or drug abuse
- Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
- Pregnant or lactating females
- Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
- Known allergy to any component of the study product or placebo
- Patients suffering from:
- Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator's judgement
- Rheumatoid arthritis
- Or patients treated with:
- Systemic steroids within one month
- Immunosuppressive drugs within three months
- Daily use of NSAIDs within one week or occasional use within 8 hours
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Germany9 sites
Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH
Bad Neustadt an der Saale, 97616
Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie
Duisburg, 47166
St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie
Essen, 45257
Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie
Homburg, 66421
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte
Lübeck, 23538
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
Munich, 80336
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern
Munich, 81377
Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
Stuttgart, 70199
Sweden4 sites
Dept. of Hand Surgery Sahlgrenska University Hospital
Gothenburg, SE-413 45
Dept. of Hand Surgery Malmö University Hospital
Malmö, SE-20502
Dept. of Hand Surgery, Stockholm South General Hospital
Stockholm, 118 83
Dept. of Hand Surgery Uppsala University Hospital, entrance 70
Uppsala, SE-75185
Denmark2 sites
Dept. of Hand Surgery, Aalborg Hospital
Aalborg, 9000
Dept. of Hand Surgery, Odense University Hospital
Odense, 5000
About this study
Official title: A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.
Read the detailed description
This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.
The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.
Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).
Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.
- Conditions
- Surgical Adhesions
- Being tested
- PXL01, Placebo
- Keywords
- Surgical Adhesions, Post-surgical adhesions, Flexor tendon
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXL01Drug
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PlaceboDrug
Placebo is a physiological sodium chloride solution, which is clear and colourless.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. Receives: Drug: Placebo |
| PXL01 | Experimental | PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. Receives: Drug: PXL01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAM2
The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.
Measured: At 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionFeb 2013
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 Surgical AdhesionsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pergamum AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Wiig, MD, PhD, Principal investigator, Dept. of Hand Surgery Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022242
- Sponsor's protocol ID
- PHSU02
- Acronym
- PHSU02
- Status last verified
- Apr 2014
- First submitted
- 25 Nov 2009
- Last updated
- 29 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wiig ME, Dahlin LB, Friden J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.
PubMed 25340801
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery
- ClinicalTrials.gov ID
- NCT01022242
- Acronym / sponsor ID
- PHSU02 / PHSU02
- Conditions
- Surgical Adhesions
- Keywords
- Surgical Adhesions, Post-surgical adhesions, Flexor tendon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Pergamum ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Posted 29 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.
Detailed description
This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.
The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.
Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).
Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
| PXL01 | Experimental | Drug: PXL01PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
- Open flexor tendon injury sutured within 14 days after trauma
- 12-75 years of age
- Signed informed consent prior to any study related procedures
Key exclusion criteria (25 listed)
- Treatment with any investigational product within 4 weeks of study entry
- Patients previously included in the study
- Thumbs with complete or partial division of flexor pollicis longus (FPL)
- Concomitant fracture(s) requiring immobilisation
- Injuries with associated soft tissue loss
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 |
|---|---|---|
| PXL01PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. | Drug | PXL01 |
| PlaceboPlacebo is a physiological sodium chloride solution, which is clear and colourless. | Drug | Placebo |
Primary outcome
TAM2
Time frame: At 12 weeks after surgery
The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25340801Wiig ME, Dahlin LB, Friden J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.
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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.
Monica Wiig, MD, PhD principal investigator
Dept. of Hand Surgery Uppsala University Hospital
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXL01 in people with Surgical Adhesions, run by Pergamum AB at 15 sites in 3 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 4 inclusion and 25 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 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Sweden, Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 May 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?
TAM2 (time frame: At 12 weeks after surgery). 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 NCT01022242, 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 29 May 2014.