Catherine Curtin
Auxilium 857-858 Clinical Trial of a Non-surgical Treatment of Dupuytrens Finger Contractures
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The study doctor and Auxilium Pharmaceuticals, Inc., the sponsoring drug company, are conducting research studies of an investigational drug called AA4500, Clostridial Collagenase for Injection. An investigational drug is one that has not been approved by the United States Food and Drug Administration for general use in the United States, but may be tested in research studies such as this one. The purpose of these studies is to test whether AA4500 will dissolve and rupture (?pop?) the cord (tissue) causing the contracture of your finger(s) due to your Dupuytren?s disease and to provide long-term follow-up for safety and evaluation of your treated finger(s).
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Collagenase by injection
Phase:
Phase 3Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key Inclusion Criteria:
1. Subject is at least 18 years of age.
2. 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.
3. 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.
4. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
5. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
6. 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
Key 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 before the first injection.
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.
Additional Study Details
Official Title:
Protocol Title: A Phase 3, Double-Blind, Randomized, Placebo Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Dupuytren?s Contracture (AUX-CC-857) AND A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren?s Contracture (AUX-CC-858)Anticipated start date:
10/16/2007Lead Sponsor:
Auxilium Pharmaceuticals Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Straightening of previously contracted joint to within 5 degrees
Secondary Outcomes:
- Patient assesses clinical improvement
Total Number to be Enrolled:
40Total Number to be Enrolled at Stanford:
40More Information
Secondary ID(s):
- Protocol # 97304, IRB # 4593
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
1/24/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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