NCT01483963

AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adhesive Capsulitis
• Frozen Shoulder

Interventions

Type	Name	Description
BIOLOGICAL	AA4500 0.29 mg/1 mL	treatment of adhesive capsulitis
BIOLOGICAL	AA4500 0.58 mg/2 mL	treatment of adhesive capsulitis
BIOLOGICAL	AA4500 0.58 mg/1 mL	treatment of adhesive capsulitis
BIOLOGICAL	AA4500 0.58 mg/0.5 mL	treatment of adhesive capsulitis
OTHER	Shoulder exercises	Home shoulder exercises, minimum of 3 times per day

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-12-02
• Last updated: 2017-10-05
• Results posted: 2017-05-25

Locations

15 sites across 1 country: United States