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NCT01483963 · ClinicalTrials.gov registry record · Phase 2

AA4500 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
50
Enrollment target
15
Study locations

NCT01483963: Completed Phase 2 study of Frozen Shoulder and Adhesive Capsulitis, sponsored by Endo Pharmaceuticals.

NCT01483963 is a Phase 2 study of Frozen Shoulder and Adhesive Capsulitis that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 50 participants, below the 200-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (75% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01483963, a Phase 2 study of Frozen Shoulder and Adhesive Capsulitis, has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
15
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

Frozen Shoulder Adhesive Capsulitis

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

FieldValue
Enrollment Target 50 participants
Start Date 2011-11
Est. Completion 2013-02
Phase Phase 2
Endo Pharmaceuticals

23 total trials

What the finished NCT01483963 record still lists

NCT01483963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 200-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (75% lower).

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.

NCT01483963 lists 15 locations in 13 states (Arizona, California, Alabama).

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.

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).

Who is sponsoring clinical trial NCT01483963?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

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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Related registry views

Source: ClinicalTrials.gov NCT01483963, the US trial registry maintained by the National Library of Medicine. NCT01483963 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.