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NCT00528931 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
A Phase 1 study of Dupuytren's Contracture, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00528931: Completed Phase 1 study of Dupuytren's Contracture, sponsored by Endo Pharmaceuticals.
NCT00528931 is a Phase 1 study of Dupuytren's Contracture that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528931, a Phase 1 study of Dupuytren's Contracture, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection. 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.
Primary Outcome
AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
Conditions Studied
Interventions
- BIOLOGICAL collagenase clostridium histolyticum
Study Locations (1)
California
- Providence Clinical Research - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00528931 record still lists
NCT00528931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Dupuytren's Contracture appearing as the primary indexed condition, and to 1 intervention - of which collagenase clostridium histolyticum is the first listed.
NCT00528931 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00528931 about?
NCT00528931 is a clinical study titled "A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture". A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal int...
What is the current status of trial NCT00528931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-09. Estimated completion is 2008-03.
What conditions does trial NCT00528931 study?
This clinical trial studies the following conditions: Dupuytren's Contracture.
What interventions are being tested in trial NCT00528931?
The interventions under investigation include: collagenase clostridium histolyticum (BIOLOGICAL).
Who is sponsoring clinical trial NCT00528931?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00528931 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528931's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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