Advanced Dupuytren's Disease Clinical Trial
— CORD-IIOfficial title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease Followed by an Open-Label Extension Phase
Verified date | October 2017 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled
phase and a nine-month open-label extension phase. Before treatment, eligible subjects were
stratified by the primary joint type (30 metacarpophalangeal [MP] joints and 30 proximal
interphalangeal [PIP] joints) and by severity of the primary joint contracture (ie, up to 50°
or >50° for MP joints and up to 40° or >40° for PIP joints) and then randomized in a 2:1
ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie,
90-day evaluation after the first injection), all subjects were eligible to enter the
open-label extension phase of the study in which they were followed for an additional nine
months. Subjects who required further treatment because they either did not achieve reduction
in contracture to 5° or less, the cord affecting the primary joint received placebo, another
cord received less than three injections of AA4500, or they had untreated cords that were
affecting other joints had the option to receive up to five additional injections of AA4500
0.58 mg in the open-label extension phase, with individual cords receiving up to three
injections of AA4500.
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 naive to AA4500 treatment - Were judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. Exclusion Criteria: - Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands. - Had received a treatment for advanced Dupuytren's disease, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug. - 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Rivercity Research | Auchenflower | Queensland |
Australia | Brisbane Hand & Upper Limb Clinic | Brisbane | Queensland |
Australia | Caboolture Clinical Research Centre | Caboolture | Queensland |
Australia | Menzies Reserarch Institute | Hobart | Tasmania |
Australia | Peninsula Clinical Research Centre | Kippa Ring | Queensland |
Australia | Emeritus Research | Malvern | Victoria |
Australia | Royal Perth Hospital | Shenton Park | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Primary Joint Contracture to 5° or Less | Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Within 30 days after last injection | |
Secondary | Clinical Improvement in Primary Joint After the Last Injection | Clinical improvement in primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection | Baseline, Within 30 days after last injection | |
Secondary | Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection | Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture | Baseline, Day 30 after last injection | |
Secondary | Change From Baseline Range of Motion in Primary Joint After the Last Injection | Change in degree of range of motion in primary joint measured as last available post-injection range of motion - baseline range of motion | Baseline, Day 30 after last injection | |
Secondary | Time to Reach Clinical Success in Primary Joint | Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories | Within 30 days after last injection | |
Secondary | Clinical Success in Primary Joint After the First Injection | Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Within 30 days after first injection | |
Secondary | Clinical Improvement in Primary Joint After the First Injection | Clinical improvement in primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection | Baseline, Within 30 days after first injection | |
Secondary | Percent Reduction From Baseline Contracture of Primary Joint After the First Injection | Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture | Baseline, Day 30 after first injection | |
Secondary | Change From Baseline Range of Motion in Primary Joint After the First Injection | Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion | Baseline, Day 30 after first injection | |
Secondary | Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection | Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Within 30 days after last injection | |
Secondary | Clinical Improvement in Non-Primary Joint After the Last Injection | Clinical improvement in non-primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection | Baseline, Within 30 days after last injection | |
Secondary | Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection | Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture | Baseline, Day 30 after last injection | |
Secondary | Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection | Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion - baseline range of motion | Baseline, Day 30 after last injection | |
Secondary | Time to Reach Clinical Success in Non-Primary Joint | Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories | Within 30 days after last injection | |
Secondary | Clinical Success in Non-Primary Joint After the First Injection | Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Within 30 days after first injection | |
Secondary | Clinical Improvement in Non-Primary Joint After the First Injection | Clinical improvement in non-primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection | Baseline, Within 30 days after first injection | |
Secondary | Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection | Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture | Baseline, Day 30 after first injection | |
Secondary | Change From Baseline Range of Motion in Non-Primary Joint After the First Injection | Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion | Baseline, Day 30 after first injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00528840 -
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 | |
Completed |
NCT00528424 -
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 |