Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
Completed · Phase 3 · Has a placebo group
Conditions studied: Pain
In brief
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 undergoing bunionectomy. Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.
Key facts
- Study ID
- NCT00656578
- Run by
- Anesiva, Inc.
- People needed
- 300
- Starts
- 2008-03-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2009-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Foot and Ankle Institute — Bakersfield, California, United States
- Crossroads Research, Inc. — Owings Mills, Maryland, United States
- Scirex Research Center — Austin, Texas, United States
- San Antonio Podiatry Associates, PC — San Antonio, Texas, United States
- Hill Country Sports Medicine of Podiatric Surgery — San Marcos, Texas, United States
- Scirex Research Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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