Clinical Trial: AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture
Brief Summary:
This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
Detailed Summary:
Sponsor: Endo Pharmaceuticals
Current Primary Outcome: Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection [ Time Frame: Within 30 days after the last injection ]
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 203 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
The Primary Outcome Measure for placebo treated patients is the percentage of 103 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Original Primary Outcome: Clinical success of the primary joint [ Time Frame: Within 30 days after the last injection ]
Current Secondary Outcome:
- Clinical Improvement After the Last Injection [ Time Frame: 30 days after last treatment to the primary joint ]
- Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment to the primary joint ]
- Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment to the primary joint ]
- Time to First Achieve and Maintain Clinical Success After the Last Injection [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint ]
- Clinical Success After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ]
- Clinical Improvement After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ]
- Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ]
- Change From Baseline Range of Motion After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ]
Original Secondary Outcome:
- Clinical improvement of the primary joint.
- Percent reduction from baseline in contracture of the primary joint.
- Percent change from baseline in range of motion of the primary joint.
- Time to reach clinical success of the primary joint.
Information By: Endo Pharmaceuticals
Dates:
Date Received: September 11, 2007
Date Started: August 2007
Date Completion:
Last Updated: September 7, 2016
Last Verified: July 2016