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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 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.

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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.

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

Sponsor

Endo Pharmaceuticals

23 total trials

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What the Registry Record Tells You About NCT01483963

The ClinicalTrials.gov registry entry for NCT01483963 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (75% lower). The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

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 reports 15 study locations spanning 13 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.