Clinical trial NCT01498640: Retreatment of Recurrent Dupuytren's Contractures
Official title: Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dupuytren's Disease
Keywords: XIAFLEX
XIAPEX
Dupuytren's disease
contracture
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

Detailed description: Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Be currently participating in the AUX-CC-860 follow-up study
3. Have at least one joint with all of the following:

   * The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
   * The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
   * A palpable cord is present in the joint to be treated
4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

1. Is a pregnant or lactating female or female intending to become pregnant during the study
2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500

Primary outcomes:
measure: Clinical Success
timeFrame: 30 days after last injection
measure: Percent Change From Baseline in Degree of Contracture
timeFrame: Baseline and 30 days after last injection
measure: Change in Range of Motion
timeFrame: Baseline and 30 days after last injection
Secondary outcomes:
measure: Physician Global Assessment of Improvement
timeFrame: 30 days after last injection
measure: Subject Global Assessment of Satisfaction
timeFrame: 30 days after last injection
measure: Recurrence of Contracture
timeFrame: Day 365
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Indianapolis
country: United States
facility: The Indiana Hand to Shoulder Center
state: Indiana
city: Marquette
country: United States
facility: Marquette General Health System
state: Michigan
city: New York
country: United States
facility: East River Professional Building
state: New York
city: Oklahoma City
country: United States
facility: Health Reserarch Institute
state: Oklahoma
city: Erie
country: United States
facility: Hand Microsurgery and Reconstructive Orthopaedics
state: Pennsylvania
city: Kippa Ring
country: Australia
facility: Peninsula Private Hospital
state: Queensland
city: Sherwood
country: Australia
facility: AusTrials Sherwood
state: Queensland
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Uppsala
country: Sweden
facility: Uppsala Akademiska University Hospital
state: SE
city: Derby
country: United Kingdom
facility: Pulvertaft Hand Center
state: GB
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals
state: GB
Study officials:
affiliation: Endo Pharmaceuticals
name: Veronica Urdaneta, MD, MPPH
role: STUDY_DIRECTOR
References: