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Clinical Trial Summary

OBJECTIVES:

Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.


Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.

Completion date provided represents the completion date of the grant per OOPD records ;


Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004409
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase Phase 2
Start date August 1995
Completion date April 2004

See also
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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
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Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01265420 - Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb Phase 4
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) 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 NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3