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Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

NCT00656578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-05-04

No results posted yet for this study

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

Interventions

DRUG

4975

Single dose, solution

DRUG

Placebo

Single dose, solution

Sponsors & Collaborators

  • Anesiva, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656578 on ClinicalTrials.gov