Dupuytren's DiseasePhase 3NCT00260429
Collagenase in the Treatment of Dupuytrens Disease
A Phase 3 study testing collagenase clostridium histolyticum in people with Dupuytren's Disease, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- collagenase clostridium histolyticum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects were at least 18 years of age, of either sex or any race.
- Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the finger(s) of at least 20 degrees or greater, caused by a palpable cord.
- Subjects had a positive "table-top test" defined as the inability to simultaneously place their affected finger(s) and palm flat against a table top.
- Subjects must have been willing to participate in and complete the study, and comply with its procedures by signing an IRB approved written consent form.
- Subjects must have been able to understand and adhere to the visit schedule. They must have been able to follow study procedures and instructions, and have agreed to report concomitant medications and adverse events accurately and consistently.
- Women of childbearing potential must have agreed to use an acceptable method of birth control or must have been surgically sterilized (hysterectomy or tubal ligation). Women of childbearing age had a urine pregnancy test on Day 0 (day of injection) prior to the injection.
Who cannot join
- Women who were nursing or who were pregnant (as evidenced by a positive urine pregnancy test at the time of enrollment).
- Subjects who had participated in an investigational drug trial within 30 days of enrollment in this study.
- Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment in this study.
- Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the AA4500 injection.
- Subjects who had a known allergy to doxycycline.
- Subjects who had a medical condition that would have made them unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital and Mediacl Center
Stony Brook, New York, 11794
About this study
Official title: Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Read the detailed description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.
Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.
- Conditions
- Dupuytren's Disease
- Being tested
- collagenase clostridium histolyticum
- Keywords
- Dupuytren's contracture, fixed flexion contracture
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagenase clostridium histolyticumBiological
Also called XIAFLEX®, AA4500
Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
| Study group | Role | What they receive |
|---|---|---|
| AA4500 0.58 mg | Experimental | Not described Receives: Biological: collagenase clostridium histolyticum |
| placebo | Placebo comparator | Not described Receives: Biological: collagenase clostridium histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Measured: 30 days after the last injection
Secondary outcomes (6)
Percent Reduction From Baseline Contracture After the Last Injection
Measured: 30 days after last treatment to the primary joint
Percent Change From Baseline Range of Motion After the Last Injection
Measured: 30 days after last treatment to the primary joint
Time to First Achieve and Maintain Clinical Success After the Last Injection
Measured: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint
Clinical Success After the First Injection
Measured: 30 days after first treatment to the primary joint
Percent Reduction From Baseline Contracture After the First Injection
Measured: 30 days after first treatment to the primary joint
Change From Baseline Range of Motion After the First Injection
Measured: 30 days after first treatment to the primary joint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJun 2003
- Primary completionAug 2005
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Biospecifics Technologies Corp., Endo USA Inc., a Keenova Therapeutics Company
- Investigators
- Lawrence C Hurst, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260429
- Sponsor's protocol ID
- DUPY 303
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2005
- Last updated
- 9 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.
PubMed 12239666
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.
- ClinicalTrials.gov ID
- NCT00260429
- Acronym / sponsor ID
- DUPY 303
- Conditions
- Dupuytren's Disease
- Keywords
- Dupuytren's contracture, fixed flexion contracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Biospecifics Technologies Corp., Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Jun 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Posted 9 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Detailed description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.
Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA4500 0.58 mg | Experimental | Biological: collagenase clostridium histolyticum |
| placebo | Placebo comparator | Biological: collagenase clostridium histolyticum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects were at least 18 years of age, of either sex or any race.
- Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the finger(s) of at least 20 degrees or greater, caused by a palpable cord.
- Subjects had a positive "table-top test" defined as the inability to simultaneously place their affected finger(s) and palm flat against a table top.
- Subjects must have been willing to participate in and complete the study, and comply with its procedures by signing an IRB approved written consent form.
- Subjects must have been able to understand and adhere to the visit schedule. They must have been able to follow study procedures and instructions, and have agreed to report concomitant medications and adverse events accurately and consistently.
Key exclusion criteria (6 listed)
- Women who were nursing or who were pregnant (as evidenced by a positive urine pregnancy test at the time of enrollment).
- Subjects who had participated in an investigational drug trial within 30 days of enrollment in this study.
- Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment in this study.
- Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the AA4500 injection.
- Subjects who had a known allergy to doxycycline.
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 clostridium histolyticumAlso: XIAFLEX®, AA4500Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections. | Biological | AA4500 0.58 mg, placebo |
Primary outcome
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
Time frame: 30 days after the last injection
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
6 secondary outcomes
Percent Reduction From Baseline Contracture After the Last Injection
Time frame: 30 days after last treatment to the primary joint
Percent Change From Baseline Range of Motion After the Last Injection
Time frame: 30 days after last treatment to the primary joint
Time to First Achieve and Maintain Clinical Success After the Last Injection
Time frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint
Clinical Success After the First Injection
Time frame: 30 days after first treatment to the primary joint
Percent Reduction From Baseline Contracture After the First Injection
Time frame: 30 days after first treatment to the primary joint
Change From Baseline Range of Motion After the First Injection
Time frame: 30 days after first treatment to the primary joint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12239666Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.
- XIAFLEX Prescribing InformationLink provided by the sponsor.
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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, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing collagenase clostridium histolyticum in people with Dupuytren's Disease, run by Stony Brook University at 1 site 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?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint. (time frame: 30 days after the last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260429, which also lists 1 linked publication.
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 9 Dec 2010.