Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development State University of New York
|
---|---|
Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
Dupuytren's Contracture |
Drug: collagenase |
Phase II |
MedlinePlus related topics: Connective Tissue Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Expected Total Enrollment: 36
Study start: August 1995
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |