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Completed

NCT Number: NCT00681356

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

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

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Key information

Conditions

Total Knee Arthroplasty (Replacement)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

Loading trial locations.

About this study

The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III
  • Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)

Key Exclusion Criteria:

  • A body mass index (BMI) greater than 43
  • Known bleeding disorder or is taking agents affecting coagulation preoperatively
  • Use of medications or 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
  • Previous knee arthroplasty (partial or total) of the same knee
  • Participated in another clinical trial within 30 days prior to the planned TKA surgery

Treatment and study plan

4975, 15 and 5 mg

Drug

Direct instillation into the surgical site

Other names: Adlea

placebo comparator

Drug

Direct instillation into the surgical site

4975 - 5 mg

Drug

Direct instillation into the surgical site

Primary outcomes

  1. Numerical Rating Scale (NRS) measures of pain at prespecified times

    Time frame: Primary endpoint is 2 days (4-48 hours)

Secondary outcomes

  1. Other efficacy parameters, safety and tolerability of 4975

    Time frame: 42 Days or Early Termination

Sponsors and collaborators

Lead sponsor

Anesiva, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 21, 2008
Registry last updated
May 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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