A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Sponsors
Source
Endo Pharmaceuticals
Oversight Info
Has Dmc
No
Brief Summary
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857
(NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study
AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further
treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or
proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less,
the cord affecting that joint received less than three injections of AA4500, or they had
other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option
to receive up to five injections of AA4500 in this extension study. Subjects requiring
further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each
injection, with injections separated by four weeks. Follow-up visits for the determination of
efficacy and safety were conducted on Day 90, Month 6, and Month 9.
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.
Overall Status
Completed
Start Date
2007-12-01
Completion Date
2008-11-01
Primary Completion Date
2008-11-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Reduction in Contracture to 5° or Less |
Within 30 days after last injection |
Secondary Outcome
Measure |
Time Frame |
|
Clinical Improvement After the Last Injection |
Baseline, within 30 days after last injection |
|
Percent Reduction From Baseline Contracture After the Last Injection |
Baseline, Day 30 after last injection |
|
Change From Baseline Range of Motion After the Last Injection |
Baseline, Day 30 after last injection |
|
Time to Reach Clinical Success |
Within 30 days after last injection |
|
Clinical Success After the First Injection |
Within 30 days after first injection |
|
Clinical Improvement After the First Injection |
Baseline, within 30 days after first injection |
|
Percent Reduction From Baseline Contracture After the First Injection |
Baseline, Day 30 after first injection |
|
Change From Baseline Range of Motion After the First Injection |
Baseline, Day 30 after first injection |
Enrollment
286
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.
Arm Group Label
AA4500 0.58 mg
Other Name
XIAFLEX®
Eligibility
Criteria
Inclusion Criteria:
- Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion
deformity of at least one finger, other than the thumb, that had a contracture at
least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable
cord.
- Had a positive "table top test," defined as the inability to simultaneously place the
affected finger(s) and palm flat against a table top.
- Were naïve to AA4500 treatment or had received only one or two injections of AA4500
for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- Were judged to be in good health.
- Must have participated in protocol AUX-CC-857 (NCT00528606).
Exclusion Criteria:
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the
hands.
- Had received treatment for advanced Dupuytren's disease within 90 days of enrollment
on the joint selected for the initial injection of AA4500, including surgery
(fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of
verapamil and/or interferon.
- Had a known recent history of stroke, bleeding, a disease process that affected the
hands, or other medical condition, which in the investigator's opinion, would make the
subject unsuitable for enrollment in the study.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Veronica Urdaneta, MD |
Study Director |
Endo Pharmaceuticals |
Location
Facility |
|
100 UCLA Medical Plaza, Suite 305 Los Angeles California 90095 United States |
|
Hand Surgery Clinic Palo Alto California 94304 United States |
|
Hand Surgery Associates, PC Denver Colorado 80210 United States |
|
The Hand and Upper Extremity Center of Georgia, P.C. Atlanta Georgia 30342 United States |
|
Rockford Orthopedic Associates, Ltd. Rockford Illinois 61107 United States |
|
The Indiana Hand Center Indianapolis Indiana 46260 United States |
|
Brigham and Women's Hospital, Department of Orthopedic Surgery Boston Massachusetts 02115 United States |
|
Newton-Wellesley Hospital Newton Massachusetts 02462 United States |
|
TRIA Orthopaedic Center Minneapolis Minnesota 55431 United States |
|
Hospital for Special Surgery New York New York 10021 United States |
|
SUNY Stony Brook - Department of Orthopedics Stony Brook New York 11794 United States |
|
Health Research Institute Oklahoma City Oklahoma 73109 United States |
|
Hand Microsurgery & Reconstructive Orthopaedics Erie Pennsylvania 16550 United States |
|
University Orthopedics Center State College Pennsylvania 16801 United States |
|
Department of Orthopaedics, Brown University, Rhode Island Hospital Providence Rhode Island 02905 United States |
Location Countries
Country
United States
Verification Date
2017-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
AA4500 0.58 mg
Arm Group Type
Experimental
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
September 11, 2007
Study First Submitted Qc
September 11, 2007
Study First Posted
September 12, 2007
Last Update Submitted
October 26, 2017
Last Update Submitted Qc
October 26, 2017
Last Update Posted
December 2, 2017
Results First Submitted
September 24, 2010
Results First Submitted Qc
September 24, 2010
Results First Posted
October 22, 2010
ClinicalTrials.gov processed this data on August 28, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.