Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy - Full Text View

Sponsor:	Anesiva, Inc.
Information provided by:	Anesiva, Inc.
ClinicalTrials.gov Identifier:	NCT00656578

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: 4975 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Surgery

U.S. FDA Resources

Further study details as provided by Anesiva, Inc.:

Primary Outcome Measures:

Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety and tolerability of a single intraoperative administration of 4975 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2008
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4975	Drug: 4975 Single dose, solution
2: Placebo Comparator Drug, Single dose, solution	Drug: Placebo Single dose, solution

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656578

Locations

United States, California
Foot and Ankle Institute
Bakersfield, California, United States, 93311
United States, Maryland
Crossroads Research, Inc.
Owings Mills, Maryland, United States, 21117
United States, Texas
San Antonio Podiatry Associates, PC
San Antonio, Texas, United States, 78229
Scirex Research Center
Austin, Texas, United States, 78705
Hill Country Sports Medicine of Podiatric Surgery
San Marcos, Texas, United States, 78666
United States, Utah
Scirex Research Center
Salt Lake City, Utah, United States, 84117

Sponsors and Collaborators

Anesiva, Inc.

More Information

Additional Information:

Anesiva, Inc. Home page This link exits the ClinicalTrials.gov site

4975 Product Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anesiva, Inc. ( Denise Sharp - CRA )
Study ID Numbers:	114-08P
Study First Received:	April 7, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00656578 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anesiva, Inc.:

Foot
Bunion
Bunionectomy
Hallux Valgus Deformity
Surgery for Transpositional first metatarsal osteotomy - Bunionectomy

ClinicalTrials.gov processed this record on November 30, 2009