Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)

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NCT01229436

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Study Location
Pfizer Investigational Site
Copenhagen, , 1402 K, Denmark
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Contact
1-800-718-1021
[email protected]
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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
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
  1. Copenhagen,
  2. Silkeborg,
  3. Montpellier cedex 5,
  4. Nice,
  5. Paris,
  6. Paris,
  7. Bad Neustadt,
  8. Berlin,
  9. Bonn,
  10. Muenster,
  11. Nurnberg,
  12. Tubingen,
  13. Miskolc,
  14. Sesto San Giovanni, Milano
  15. Modena,
  16. Savona,
  17. Elche, Alicante
  18. Hospitalet De Llobregat, Barcelona/ Spain
  19. Barcelona,
  20. Barcelona,
  21. Málaga,
  22. Malmö,
  23. Stockholm,
  24. Uppsala,
  25. Derby,
  26. Glasgow,
  27. Norwich,
  28. 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
 (submitted: April 18, 2012)		254
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2010)		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:

  • 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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