Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656578
• Other study ID #: 114-08P
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2008
• Last updated: May 1, 2009
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: May 2009
• Source: Anesiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 4975
Single dose, solution
• Placebo
Single dose, solution

Locations

Country	Name	City	State
United States	Scirex Research Center	Austin	Texas
United States	Foot and Ankle Institute	Bakersfield	California
United States	Crossroads Research, Inc.	Owings Mills	Maryland
United States	Scirex Research Center	Salt Lake City	Utah
United States	San Antonio Podiatry Associates, PC	San Antonio	Texas
United States	Hill Country Sports Medicine of Podiatric Surgery	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Anesiva, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy		Prospective	No
Secondary	Evaluate safety and tolerability of a single intraoperative administration of 4975		Prospective	Yes