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

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

Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy 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:

Study is a Phase 2b, double-blind, placebo-controlled study of the safety and efficacy 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 28 days before injection of study drug.

Approximately 300 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, subjects will be randomized 3:1 to receive 0.58 mg of AA4500 or placebo. Subjects will receive up to 3 injections of study drug. Each injection will be separated by a minimum of 21 days. Subjects will also be instructed in home shoulder exercises after the first injection.


Sponsor: Endo Pharmaceuticals

Current Primary Outcome: The change (degrees) from baseline to the Day 95 follow-up in active forward flexion in the affected shoulder. [ Time Frame: Day 95 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline to Day 95 in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) function sub-scale [ Time Frame: Day 95 ]
  • Change (degrees) from baseline to the Day 95 follow-up in abduction [ Time Frame: Day 95 ]
  • Change from baseline to the Day 95 follow-up in pain with movement using a 11-point Visual Analogue Scale (VAS) [ Time Frame: Day 95 ]
  • Change (degrees) from baseline to the Day 95 follow-up in internal rotation [ Time Frame: Day 95 ]
  • Change from baseline to the Day 95 follow-up in external rotation [ Time Frame: Day 95 ]
  • Change from baseline to the Day 95 follow-up in ASES pain sub-scale [ Time Frame: Day 95 ]
  • Investigator satisfaction with treatment at the Day 95 follow-up [ Time Frame: Day 95 ]

    Degree of improvement in the severity of the subject's treated shoulder compared with screening assessed by questionnaire and rated as follows:

    1. Very Much Improved
    2. Much Improved
    3. Minimally Improved
    4. No Change
    5. Minimally Worse
    6. Much Worse
    7. Very Much Worse
  • Subject satisfaction with treatment at the Day 95 follow-up [ Time Frame: Day 95 ]

    Determined by questionnaire and rated as follows:

    1. Very Satisfied
    2. Quite Satisfied
    3. Neither Satisfied nor Dissatisfied
    4. Quite Dissatisfied
    5. Very Dissatisfied


Original Secondary Outcome: Same as current

Information By: Endo Pharmaceuticals

Dates:
Date Received: December 2, 2013
Date Started: November 2013
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015