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Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

NCT00681356 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2009-05-04

No results posted yet for this study

Summary

Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

Conditions

  • Total Knee Arthroplasty (Replacement)

Interventions

DRUG

4975, 15 and 5 mg

Direct instillation into the surgical site

DRUG

Placebo Comparator

Direct instillation into the surgical site

DRUG

4975 - 5 mg

Direct instillation into the surgical site

Sponsors & Collaborators

  • Anesiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Shaun Comfort, MD · Anesiva, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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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 NCT00681356 on ClinicalTrials.gov