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Dupuytren Contracture

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Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.

collagenase clostridium histolyticum

Lawrence C Hurst, MD

The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.

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 and AUX-CC-859) and 7 non-pivotal studies were evaluated.

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.

Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.

Collagenase in the Treatment of Dupuytrens Disease

Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.

The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 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 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.

Biospecifics Technologies Corp.

Endo Pharmaceuticals

Stony Brook University

James Tursi, MD; VP of Clinical Development

This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).

collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints

AA4500

Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Greg Kaufman, MD; Senior Director of Clinical Development

Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Collagenase in the Treatment of Dupuytrens Disease	NCT00260429	Dupuytren's Dis...	collagenase clo...	18 Years -	Stony Brook University
Collagenase in the Treatment of Dupuytrens Disease	NCT00260429	Dupuytren's Dis...	collagenase clo...	18 Years -	Stony Brook University

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