NCT00004409

Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: State University of New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Dupuytren's Contracture

Interventions

Type	Name	Description
DRUG	collagenase

Timeline

• Start date: 1995-08-01
• Completion: 2004-04-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

2 sites across 1 country: United States