Dupuytren's ContracturePhase 2NCT00004409
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
A Phase 2 study testing collagenase in people with Dupuytren's Contracture, run by State University of New York at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Contracture
- What is being tested?
- collagenase
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 1995to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Hospital
Palo Alto, California, 94304
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
About this study
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.
Read the 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
- Conditions
- Dupuytren's Contracture
- Being tested
- collagenase
- Keywords
- Dupuytren's disease, arthritis & connective tissue diseases, rare disease
- Medical subject headings
- Dupuytren Contracture, Arthritis, Connective Tissue Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagenaseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startAug 1995
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence C. Hurst, Study chair, State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004409
- Sponsor's protocol ID
- 199/13297
- Other IDs
- SUNY-SB-FDR001373, DUPY-101, DUPY-202, SUNY-SB-431-1007A, SUNY-SB-431-8804B, SUNY-SB-431-X2020
- Status last verified
- May 2001
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT00004409
- Acronym / sponsor ID
- 199/13297
- Conditions
- Dupuytren's Contracture
- Keywords
- Dupuytren's disease, arthritis & connective tissue diseases, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- State University of New YorkUniversity, hospital or other
- Study start
- Aug 1995
- Study completion
- Apr 2004
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagenase | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence C. Hurst study chair
State University of New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing collagenase in people with Dupuytren's Contracture, run by State University of New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.