Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

NCT00656578 | Completed Phase 3

• 1 other identifier: 114-08P
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Prospective

Secondary Outcomes (1)

• Evaluate safety and tolerability of a single intraoperative administration of 4975

  Prospective

Study Arms (2)

1

EXPERIMENTAL

4975

Drug: 4975

2

PLACEBO COMPARATOR

Drug, Single dose, solution

Drug: Placebo

Interventions

4975 DRUG

Single dose, solution

1

Placebo DRUG

Single dose, solution

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Anesiva, Inc.: lead

Study Sites (6)

Foot and Ankle Institute

Bakersfield, California, 93311, United States

Location

Crossroads Research, Inc.

Owings Mills, Maryland, 21117, United States

Location

Scirex Research Center

Austin, Texas, 78705, United States

Location

San Antonio Podiatry Associates, PC

San Antonio, Texas, 78229, United States

Location

Hill Country Sports Medicine of Podiatric Surgery

San Marcos, Texas, 78666, United States

Location

Scirex Research Center

Salt Lake City, Utah, 84117, United States

Location

Related Links

• Anesiva, Inc. Home page
• 4975 Product Information

MeSH Terms

Conditions

Pain; Bunion

Interventions

7-propyltheophylline dopamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 4, 2009

Record last verified: 2009-05

Locations

US (6)