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NCT02006719 · ClinicalTrials.gov registry record · Phase 2
Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
A Phase 2 study of Frozen Shoulder and Adhesive Capsulitis, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 322
- Enrollment target
- 20
- Study locations
NCT02006719: Completed Phase 2 study of Frozen Shoulder and Adhesive Capsulitis, sponsored by Endo Pharmaceuticals.
NCT02006719 is a Phase 2 study of Frozen Shoulder and Adhesive Capsulitis that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 322 participants, above the 109-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02006719, a Phase 2 study of Frozen Shoulder and Adhesive Capsulitis, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 322 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Primary Outcome
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Collagenase Clostridium Histolyticum
Study Locations (20)
California
- Advance Med Clinical Research - Carlsbad
- Triwest Research Associates - El Cajon
- Core Orthopedic Medical Center - Encinitas
- Temecula Rheumatology & Internal Medicine - Murrieta
- Clearview Medical Research - Santa Clarita
Florida
- Florida Research Associates - DeLand
- Shrock Orthopedic Research, LLC - Fort Lauderdale
- Jewett Orthopedic Clinic - Orlando
- Clinical Research of West Florida - Tampa
Alabama
- Alabama Orthopaedic Center-Research - Birmingham
- Coastal Clinical Research - Mobile
Illinois
- Rockford Orthopedic Associates - Rockford
- Rockford Orthopedics Associates - Rockford
Arizona
- Arizona Research Center, Inc. - Phoenix
Colorado
- Colorado Orthopedic Consultants, PC - Englewood
Georgia
- Non-Surgical Orthopedics, P.C. / Georgia Institute for Clinical Research, LLC - Marietta
Idaho
- Injury Care Medical Center - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT02006719 record still lists
NCT02006719 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, above the 109-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (195% higher).
The record links to 2 conditions, with Frozen Shoulder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02006719 names 20 study sites across 11 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02006719 about?
NCT02006719 is a clinical study titled "Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder". The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
What is the current status of trial NCT02006719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 322 participants. The study started on 2013-11. Estimated completion is 2014-12.
What conditions does trial NCT02006719 study?
This clinical trial studies the following conditions: Frozen Shoulder, Adhesive Capsulitis.
What interventions are being tested in trial NCT02006719?
The interventions under investigation include: Placebo (OTHER), Collagenase Clostridium Histolyticum (BIOLOGICAL).
Who is sponsoring clinical trial NCT02006719?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02006719 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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