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Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
4975
Placebo
Sponsored by
Anesiva, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Foot, Bunion, Bunionectomy, Hallux Valgus Deformity, Surgery for Transpositional first metatarsal osteotomy - Bunionectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foot and Ankle Institute
  • Crossroads Research, Inc.
  • Scirex Research Center
  • San Antonio Podiatry Associates, PC
  • Hill Country Sports Medicine of Podiatric Surgery
  • Scirex Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

4975

Drug, Single dose, solution

Outcomes

Primary Outcome Measures

Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy

Secondary Outcome Measures

Evaluate safety and tolerability of a single intraoperative administration of 4975

Full Information

First Posted
April 7, 2008
Last Updated
May 1, 2009
Sponsor
Anesiva, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00656578
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anesiva, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Foot, Bunion, Bunionectomy, Hallux Valgus Deformity, Surgery for Transpositional first metatarsal osteotomy - Bunionectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
4975
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Drug, Single dose, solution
Intervention Type
Drug
Intervention Name(s)
4975
Intervention Description
Single dose, solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose, solution
Primary Outcome Measure Information:
Title
Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
Evaluate safety and tolerability of a single intraoperative administration of 4975
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Foot and Ankle Institute
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Crossroads Research, Inc.
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Scirex Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
San Antonio Podiatry Associates, PC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hill Country Sports Medicine of Podiatric Surgery
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Scirex Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.anesiva.com/wt/page/pipeline
Description
Anesiva, Inc. Home page
URL
http://www.anesiva.com/wt/page/adlea
Description
4975 Product Information

Learn more about this trial

Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

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