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Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

Primary Purpose

Dupuytren's Contracture

Status
Completed
Phase
Phase 3
Locations
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 stage Dupuytren's disease with fixed flexion deformity of the finger(s) 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-- At least 30 days since prior surgery for Dupuytren's disease At least 30 days since prior participation in a trial with an 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, angina, or myocardial infarction within the past 6 months Pulmonary: No history of respiratory disease Other: Not immunocompromised HIV negative No history of significant illness (e.g., endocrine or neurologic disease) No psychosis No history of illicit drug abuse or alcoholism within the past year No infectious illness within the past 2 weeks No chronic or debilitating disease No IgE antibodies to collagenase exceeding 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the drug No other condition or circumstance that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 10, 2001
    Last Updated
    March 24, 2015
    Sponsor
    State University of New York
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00014742
    Brief Title
    Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (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: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity, range of finger motion, and grip strength in patients with residual stage Dupuytren's disease. II. Compare the overall clinical success rate, time to return to normal finger contracture to within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of patients treated with these regimens. III. Compare the baseline change in degree of finger flexion deformity, range of motion of the treated finger, and strength of hand grip (in pounds) in patients treated with these regimens. IV. Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal (zero degrees) and the number who require re-treatment with open-label collagenase after treatment with these regimens.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive a single collagenase injection into the target finger cord on day 0. Arm II: Patients receive a single placebo injection as in arm I. Both arms: After the 1 month evaluation, patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections. Beginning at 1 day after completion of treatment, patients use a joint nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, monthly for 3 months, every 3 months for 9 months, and then annually for 4 years. 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 3
    Allocation
    Randomized
    Enrollment
    72 (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 stage Dupuytren's disease with fixed flexion deformity of the finger(s) 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-- At least 30 days since prior surgery for Dupuytren's disease At least 30 days since prior participation in a trial with an 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, angina, or myocardial infarction within the past 6 months Pulmonary: No history of respiratory disease Other: Not immunocompromised HIV negative No history of significant illness (e.g., endocrine or neurologic disease) No psychosis No history of illicit drug abuse or alcoholism within the past year No infectious illness within the past 2 weeks No chronic or debilitating disease No IgE antibodies to collagenase exceeding 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the drug No other condition or circumstance that would preclude study Not pregnant or nursing Negative pregnancy test 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

    12. IPD Sharing Statement

    Learn more about this trial

    Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

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