Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01265420
Other study ID # IHtSC-Thumb 101
Secondary ID
Status Completed
Phase Phase 4
First received December 21, 2010
Last updated April 8, 2015
Start date December 2010
Est. completion date February 2014

Study information

Verified date April 2015
Source Indiana Hand to Shoulder Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb

- First web space contracture with a palpable cord due to Dupuytren's contracture

Exclusion Criteria:

- Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.

- Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).

- Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.

- Any subject with known allergy to Xiaflex (Clostridial collagenase).

- Pregnant or nursing female

- Any subject who cannot conform to the study visit schedule

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
Injectable clostridial collagenase
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Locations

Country Name City State
United States Indiana Hand to Shoulder Center Indianaplis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana Hand to Shoulder Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) 30 days after last injection No
See also
  Status Clinical Trial Phase
Completed NCT01715467 - CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment N/A
Completed NCT01674634 - Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures Phase 3
Completed NCT01407068 - Administration of Two Injections for Multiple Dupuytren's Contractures Phase 3
Completed NCT00528931 - A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture Phase 1
Completed NCT00565019 - Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture Phase 3
Completed NCT01588353 - Collagenase Option for Reduction of Dupuytren's Contracture in Japan Phase 3
Completed NCT00468949 - Health-Related Quality of Life in Patients With Dupuytren's Disease Phase 1
Completed NCT01444729 - Post Approval Commitment Study N/A
Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase 3
Completed NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00931567 - Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing Phase 2/Phase 3
Completed NCT00004409 - Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease Phase 2
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3