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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00014742
First Posted: April 11, 2001
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  Purpose

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.


Condition Intervention Phase
Dupuytren's Contracture Drug: collagenase Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 72
Estimated Study Completion Date: April 2004
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014742


Sponsors and Collaborators
State University of New York
Investigators
Study Chair: Lawrence C. Hurst State University of New York
  More Information

ClinicalTrials.gov Identifier: NCT00014742     History of Changes
Other Study ID Numbers: 199/15764
SUNY-SB-FDR001437
First Submitted: April 10, 2001
First Posted: April 11, 2001
Last Update Posted: March 25, 2015
Last Verified: April 2001

Keywords provided by FDA Office of Orphan Products Development:
Dupuytren's disease
arthritis & connective tissue diseases
rare disease

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases