Clinical trial NCT00656578: Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of a Single Intraoperative Administration of 4975 in Patients Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Foot
Bunion
Bunionectomy
Hallux Valgus Deformity
Surgery for Transpositional first metatarsal osteotomy - Bunionectomy
Lead sponsor: Anesiva, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 undergoing bunionectomy.

Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.

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. Upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo.

After the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. While at the clinical study site, patients will undergo safety and efficacy assessments. After discharge, patients will report pain severity daily through Day 14 via an interactive voice response system (IVRS). Also, safety and patient-reported outcome assessments will be performed at the Day 14 (Week 2) and Day 28 (Week 4) clinic visits.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy
timeFrame: Prospective
Secondary outcomes:
measure: Evaluate safety and tolerability of a single intraoperative administration of 4975
timeFrame: Prospective
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Foot and Ankle Institute
state: California
city: Owings Mills
country: United States
facility: Crossroads Research, Inc.
state: Maryland
city: Austin
country: United States
facility: Scirex Research Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Podiatry Associates, PC
state: Texas
city: San Marcos
country: United States
facility: Hill Country Sports Medicine of Podiatric Surgery
state: Texas
city: Salt Lake City
country: United States
facility: Scirex Research Center
state: Utah
Study officials:
References: