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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
State University of New York
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00014742
First received: April 10, 2001
Last updated: June 23, 2005
Last verified: April 2001
  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

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

Estimated Enrollment: 72
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014742

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

No publications provided

ClinicalTrials.gov Identifier: NCT00014742     History of Changes
Other Study ID Numbers: 199/15764, SUNY-SB-FDR001437
Study First Received: April 10, 2001
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Connective Tissue Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 22, 2014