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

Primary Purpose

Dupuytren's Contracture

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
collagenase
Sponsored by
State University of New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren's Contracture focused on measuring Dupuytren's disease, arthritis & connective tissue diseases, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart failure within 6 months No angina within 6 months No myocardial infarction within 6 months Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No history of significant illness, e.g., endocrine or neurologic disease No history of illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since infectious illness No chronic or debilitating disease No IgE antibodies to collagenase greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the injection Not pregnant or nursing Fertile patients must use effective contraception

Sites / Locations

  • Stanford University Hospital
  • State University of New York Health Sciences Center - Stony Brook

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
State University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT00004409
Brief Title
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2001
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
State University of New York

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Contracture
Keywords
Dupuytren's disease, arthritis & connective tissue diseases, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
collagenase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart failure within 6 months No angina within 6 months No myocardial infarction within 6 months Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No history of significant illness, e.g., endocrine or neurologic disease No history of illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since infectious illness No chronic or debilitating disease No IgE antibodies to collagenase greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the injection Not pregnant or nursing Fertile patients must use effective contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence C. Hurst
Organizational Affiliation
State University of New York
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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