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NCT00528606 · ClinicalTrials.gov registry record · Phase 3
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
NCT00528606: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00528606 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 308 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528606, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
Study Summary
This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo. 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 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL collagenase clostridium histolyticum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00528606
The ClinicalTrials.gov registry entry for NCT00528606 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00528606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00528606 about?
NCT00528606 is a clinical study titled "AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture". This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other t...
What is the current status of trial NCT00528606?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2007-08. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00528606?
The interventions under investigation include: Placebo (BIOLOGICAL), collagenase clostridium histolyticum (BIOLOGICAL).
Who is sponsoring clinical trial NCT00528606?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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