Ignite Creation Date:
2024-05-06 @ 2:17 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02006719
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2013-12-02
Brief Title:
Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AC
Brief Summary:
The objectives of this study are to assess the safety effectiveness and immunogenicity of AA4500 in the treatment of adhesive capsulitis
Detailed Description:
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 31 to receive 058 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
Approximately 300 adult women and men are to be enrolled in this study Following screening and determination of study eligibility subjects will be randomized 31 to receive 058 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None