None listed
Conditions
Brief summary
The purpose of the study is to test whether injections of AA4500 are safe and will dissolve the cord of tissue causing the bending of the finger(s) due to Dupuytren's disease.
Interventions
Double blind phase:
0.58mg of Clostridial collagenase (AA4500) or placebo will be injected directly into the Dupuytren's cord. 30 days after this first injection, if no response is seen or if the first cord responds and the patient has an additional Dupuytren's cord to be treated, a second dose of AA4500 or placebo will be injected directly either into the initially injected Dupuytren's cord or into the second Dupuytren's cord as appropriate. In the double blind phase a maximum of 3 AA4500/pl
Double blind phase: 0.58mg of Clostridial collagenase (AA4500) or placebo will be injected directly into the Dupuytren's cord. 30 days after this first injection, if no response is seen or if the first cord responds and the patient has an additional Dupuytren's cord to be treated, a second dose of AA4500 or placebo will be injected directly either into the initially injected Dupuytren's cord or into the second Dupuytren's cord as appropriate. In the double blind phase a maximum of 3 AA4500/placebo injections will be given, each 30 days apart. Open label phase: 0.58mg of Clostridial collagenase (AA4500) will be injected directly into the Dupuytren's cord. 30 days after the first open label injection, if no response is seen or if the previously injected cord responds and the patient has an additional Dupuytren's cord to be treated, a second dose of open label AA4500 will be injected directly either into the initially injected Dupuytren's cord or into the second Dupuytren's cord as appropriate. In the open label phase a maximum of 5 injections will be given, 30 days apart. Hence, a subject can receive up to 8 injections (3 in the double blind phase, 5 in the open label phase), but if they only have 1 Dupuytren's cord to treat and respond to the first injection they will not proceed with any further injections and will enter the follow-up phase of the study. Follow-up phase: Subjects will be reviewed at 3, 6, 9 and 12 months after the first injection. At these visits the study objectives will be reviewed.
Sponsors
Auxilium Pharmaceuticals, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has a diagnosis of Dupuytren’s contracture with a fixed flexion deformity of the finger(s) of at least 20° or no greater than 100° for MP (80° for PIP) contracture, caused by a palpable cord. 2. Subject has a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 3. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. 4. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). 5. Female subjects of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study.
Exclusion criteria
1. Female subjects who are nursing or pregnant, or plan to become pregnant during the treatment phase.2. Subject has received an investigational drug within 30 days prior to the first dose of study drug.3. Subject has received a treatment on the selected primary joint(s), within 90 days of enrollment in the study, for Dupuytren’s contracture including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.4. Subject has a known allergy to collagenase or any other excipient of AA4500.5. Subject has received doxycycline or doxycycline derivative during the 14 days prior to the first dose of study drug.6. Subject has received any collagenase treatments within 30 days.7. Subject is receiving anticoagulant medication or has received anticoagulant medication (except for aspirin = 150 mg daily) within 7 days of enrollment in this study.8. Subject has a known recent history of stroke, bleeding, or other medical condition which in the investigator’s opinion would make the subject unsuitable for enrollment in the study.
Outcome results
None listed