Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
NCT01229436
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dupuytren's Contracture
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Dupuytren's ContractureTreatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
NCT01229436
- Copenhagen,
- Silkeborg,
- Montpellier cedex 5,
- Nice,
- Paris,
- Paris,
- Bad Neustadt,
- Berlin,
- Bonn,
- Muenster,
- Nurnberg,
- Tubingen,
- Miskolc,
- Sesto San Giovanni, Milano
- Modena,
- Savona,
- Elche, Alicante
- Hospitalet De Llobregat, Barcelona/ Spain
- Barcelona,
- Barcelona,
- Málaga,
- Malmö,
- Stockholm,
- Uppsala,
- Derby,
- Glasgow,
- Norwich,
- Southampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) | |||
| Official Title ICMJE | Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex) | |||
| Brief 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. 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Dupuytren's Contracture | |||
| Intervention ICMJE | Drug: Xiapex
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 Arms ICMJE | Experimental: Xiapex Injection
Intervention: Drug: Xiapex | |||
| 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 254 | |||
| Original Estimated Enrollment ICMJE | 250 | |||
| Actual Study Completion Date ICMJE | October 2012 | |||
| Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Denmark, France, Germany, Hungary, Italy, Spain, Sweden, United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01229436 | |||
| Other Study ID Numbers ICMJE | B1531002 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||