Clinical Trial: AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a, Open-label, Dose-ranging Study of the Safety and Effectiveness of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

Brief Summary: The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.

Detailed Summary:

This study is a Phase 2a, open-label, dose-ranging study of the safety and effectiveness of AA4500 for the treatment of adhesive capsulitis of the shoulder. To be eligible for treatment, a subject must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least 3 months but not more than 12 months. Subjects will be screened for study eligibility within 30 days before injection of study drug.

Approximately 50 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, Assignment to Cohorts 1-4 is sequential. Subjects assigned to Cohorts 1 through 4 may receive up to 3 injections of AA4500 according to cohort assignment. Each injection will be separated by a minimum of 21 days. Subjects assigned to Cohort 5 will receive home shoulder exercises only, while subjects assigned to Cohorts 1-4 will receive AA4500 and home shoulder exercises. Subjects in Cohort 5 will be offered physical therapy sessions for a period of 2 months following completion of the study.

Dosing will range from 0.29 mg to 0.58 mg with varying volumes.


Sponsor: Endo Pharmaceuticals

Current Primary Outcome: Change (degrees) from baseline in active forward flexion in the affected shoulder [ Time Frame: Day 92 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change (degrees) from baseline in passive forward flexion in the affected shoulder [ Time Frame: Day 92 ]
  • Change (degrees) from baseline in abduction (active and passive) [ Time Frame: Day 92 ]
  • Change (degrees) from baseline in external rotation at 90°abduction (active and passive) [ Time Frame: Day 92 ]
  • Change from baseline in internal rotation with the elbow at 90°abduction (active and passive) [ Time Frame: Day 92 ]


Original Secondary Outcome: Same as current

Information By: Endo Pharmaceuticals

Dates:
Date Received: November 30, 2011
Date Started: November 2011
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015