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AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
NCT01483963 · View on ClinicalTrials.gov ↗
Study Summary
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Conditions Studied
Interventions
- BIOLOGICAL AA4500 0.29 mg/1 mL
- BIOLOGICAL AA4500 0.58 mg/2 mL
- BIOLOGICAL AA4500 0.58 mg/1 mL
- BIOLOGICAL AA4500 0.58 mg/0.5 mL
- OTHER Shoulder exercises
Study Locations (15)
Arizona
- HOPE Research Institute — Phoenix
- Tucson Orthopaedic Institute — Tucson
California
- CORE Orthopaedic Medical Center — Encinitas
- Triwest Research Associates — La Mesa
Alabama
- Alabama Orthopaedic Center - Research — Birmingham
Arkansas
- OrthoArkansas — Little Rock
Florida
- Advent Clinical Research — Pinellas Park
Illinois
- Rockford Orthopedic Associates — Rockford
Indiana
- The Indiana Hand to Shoulder Center — Indianapolis
New York
- Stony Brook University Medical Center — Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01483963
The ClinicalTrials.gov registry entry for NCT01483963 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Frozen Shoulder appearing as the primary indexed condition, and to 5 interventions — of which AA4500 0.29 mg/1 mL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01483963 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Arizona, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01483963 about?
NCT01483963 is a clinical study titled "AA4500 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 NCT01483963?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2011-11. Estimated completion is 2013-02.
What conditions does trial NCT01483963 study?
This clinical trial studies the following conditions: Frozen Shoulder, Adhesive Capsulitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01483963?
The interventions under investigation include: AA4500 0.29 mg/1 mL (BIOLOGICAL), AA4500 0.58 mg/2 mL (BIOLOGICAL), AA4500 0.58 mg/1 mL (BIOLOGICAL), AA4500 0.58 mg/0.5 mL (BIOLOGICAL), Shoulder exercises (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01483963?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01483963 being conducted?
This trial has 15 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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