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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 is a Phase 1 study of Dupuytren's Contracture that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00528931
The ClinicalTrials.gov registry entry for NCT00528931 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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