Dupuytren's ContractureNCT01444729
Post Approval Commitment Study
An observational study of Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in 2 countries.
Trial summary
An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Contracture
- What is being tested?
- Xiapex and surgery
- Type of treatment
- Surgery or procedure
- How many people
- 305 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2012to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Who may be able to join
- Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Who cannot join
- none
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain5 sites
Auxilium Investigational Site
Alcorcón, Madrid, 28922
Auxilium Investigational Site
Majadahonda, Madrid, 28222
Auxilium Investigational Site
Málaga, Andalusia, 29010
Auxilium Investigational Site
Pamplona, Navarre, 31008
Auxilium Investigational Site
Valladolid, 46011
Norway2 sites
Auxilium Investigational Site
Bergen, 5021
Auxilium Investigational Site
Drammen, 3004
About this study
Official title: A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.
Read the detailed description
phase 4, open label, multi-center, prospective non-interventional descriptive
- Conditions
- Dupuytren's Contracture
- Being tested
- Xiapex, surgery
- Keywords
- 'Dupuytren's contracture', 'xiapex', 'surgery'
- 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 administration will follow SMPC
surgeryProcedure or surgery
Non-pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| xiapex | Subject treated with Xiapex Receives: Drug: Xiapex | |
| Surgery | Fasciotomy or fasciectomy Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical treatment success as assessed by goniometry
Measured: an expected average of 5 weeks
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
Measured: an expected average of 5 weeks
Secondary outcomes (1)
Treatment option as determined by treating physician in consultation with patient
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's ContractureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Urdaneta, Study director, Endo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444729
- Sponsor's protocol ID
- B1531005
- Status last verified
- Oct 2017
- First submitted
- 8 Sep 2011
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
- ClinicalTrials.gov ID
- NCT01444729
- Acronym / sponsor ID
- B1531005
- Conditions
- Dupuytren's Contracture
- Keywords
- 'Dupuytren's contracture', 'xiapex', 'surgery'
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.
Detailed description
phase 4, open label, multi-center, prospective non-interventional descriptive
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xiapex | – | Drug: XiapexSubject treated with Xiapex |
| Surgery | – | Procedure: surgeryFasciotomy or fasciectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Key inclusion criteria (1 listed)
- Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Key exclusion criteria (1 listed)
- none
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 administration will follow SMPC | Drug | xiapex |
| surgeryNon-pharmacological treatment | Procedure or surgery | Surgery |
Primary outcome
clinical treatment success as assessed by goniometry
Time frame: an expected average of 5 weeks
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
Time frame: an expected average of 5 weeks
1 secondary outcome
Treatment option as determined by treating physician in consultation with patient
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Related trials for Dupuytren's Contracture
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Active, not recruiting
Skin Involvement in Dupuytren Surgical Treatment Outcome
Dupuytren Disease
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.
Veronica Urdaneta study director
Endo
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in 2 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 1 inclusion and 1 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical treatment success as assessed by goniometry (time frame: an expected average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2017.