Safety and Efficacy of AA4500 injections for Dupuytren's contractures

• Research type

  Research Study

• Full title

  A Phase 3b open-label, historically-controlled study to assess the safety and efficacy of two concurrent injections of AA4500 in adult subjects with multiple Dupuytren's contractures with palpable cords.

• IRAS ID

  114396

• Contact name

  Christopher Bainbridge

• Sponsor organisation

  Auxilium UK Limited

• Eudract number

  2012-004091-19

• Clinicaltrials.gov Identifier

  NCT01674634

• Research summary

  The objectives of this study are to assess the safety and efficacy of 2 concurrent injections of AA4500 (collagenase clostridium histolyticum (Xiaflex/Xiapex)) into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure if required. Success of the treatment will be defined as the reduction in the sum of the fixed flexion measurements of the two simultaneously treated joints, and change from baseline in total range of motion, defined as the sum of the range of motion measurements of the two simultaneously treated joints.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0437

• Date of REC Opinion

  24 Dec 2012

• REC opinion

  Further Information Favourable Opinion