- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004409
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
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.
Study Overview
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University Hospital
-
-
New York
-
Stony Brook, New York, United States, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13297
- SUNY-SB-FDR001373
- DUPY-101
- DUPY-202
- SUNY-SB-431-1007A
- SUNY-SB-431-8804B
- SUNY-SB-431-X2020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dupuytren's Contracture
-
University of MinnesotaRecruitingDupuytren Contracture | Dupuytren Disease of Finger | Dupuytren's Disease | Dupuytren Disease of Palm and Finger | Dupuytrens Contracture of Both Hands | Dupuytren's Disease of Palm of Right Hand | Dupuytren's Disease of Palm of Left Hand | Dupuytren Contracture of Right Palm | Dupuytren Contracture... and other conditionsUnited States
-
Catherine Vandepitte, M.D.Pacira Pharmaceuticals, IncCompletedDupuytren's Contracture of the Hand (Viking's Disease)Belgium
-
Uppsala UniversityRecruitingDupuytren Contracture | Dupuytren's DiseaseSweden
-
Hospital for Special Surgery, New YorkAuxilium Pharmaceuticals, Inc.CompletedDupuytren's DiseaseUnited States
-
Indiana Hand to Shoulder CenterStony Brook UniversityTerminatedDupuytren's DiseaseUnited States
-
Foundation for Orthopaedic Research and EducationEndoPharmceuticalsActive, not recruitingDupuytren Contracture | Dupuytren's DiseaseUnited States
-
Theresa Bass-GoldmanEndo PharmaceuticalsCompleted
-
Technische Universität DresdenPfizer; GWT-TUD GmbHCompleted
-
Massachusetts General HospitalCompleted
-
Regionshospitalet SilkeborgRecruitingNeoplasms | Neoplasms, Connective and Soft Tissue | Neoplasms by Histologic Type | Joint Diseases | Musculoskeletal Diseases | Connective Tissue Diseases | Neoplasms, Connective Tissue | Fibroma | Contracture | Dupuytren Contracture | Dupuytren's Disease | Neoplasm, Fibrous TissueDenmark
Clinical Trials on collagenase
-
Stony Brook UniversityCompletedAdhesion of Flexor Tendon of HandUnited States
-
Azidus BrasilSuspended
-
Stony Brook UniversityWithdrawnAdhesive Capsulitis | Frozen ShoulderUnited States
-
HealthpointCompleted
-
State University of New YorkCompletedDupuytren's Contracture
-
Endo PharmaceuticalsCompletedEdematous SkinUnited States
-
Zachary GerutAdvance Biofactures CorporationCompleted
-
Sheba Medical CenterUnknown
-
National Taiwan University HospitalUnknownAlkaline Chemical Burn Of Cornea And Conjunctival Sac | Acid Chemical Burn Of Cornea And Conjunctival Sac | Benign Mucous Membrane Pemphigoid With Ocular InvolvementTaiwan
-
University Hospital, GhentTerminatedEsophageal Stricture | Stricture | Anastomotic | CollagenosisBelgium