Status:
COMPLETED
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
Lead Sponsor:
Anesiva, Inc.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoin...
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the US. A dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. Upo...
Eligibility Criteria
Inclusion
- Male or female aged 18 years and older.
- Planning to undergo unilateral transpositional first metatarsal osteotomy for correction of Hallux Valgus Deformity (referred to as bunionectomy in this protocol).
Exclusion
- Use of certain medications or having a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments.
- Diabetes mellitus with a known HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes.
- Participated in another clinical trial or used an investigational product within 30 days prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than 4975 while participating in the study.
- Previously participated in a clinical study with 4975.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00656578
Start Date
March 1 2008
End Date
September 1 2008
Last Update
May 4 2009
Active Locations (6)
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1
Foot and Ankle Institute
Bakersfield, California, United States, 93311
2
Crossroads Research, Inc.
Owings Mills, Maryland, United States, 21117
3
Scirex Research Center
Austin, Texas, United States, 78705
4
San Antonio Podiatry Associates, PC
San Antonio, Texas, United States, 78229