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

This study has been completed.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00681356
First received: May 16, 2008
Last updated: May 1, 2009
Last verified: May 2009

May 16, 2008
May 1, 2009
September 2007
September 2008   (final data collection date for primary outcome measure)
Numerical Rating Scale (NRS) measures of pain at prespecified times [ Time Frame: Primary endpoint is 2 days (4-48 hours) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00681356 on ClinicalTrials.gov Archive Site
Other efficacy parameters, safety and tolerability of 4975 [ Time Frame: 42 Days or Early Termination ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Total Knee Arthroplasty (Replacement)
  • Drug: 4975, 15 and 5 mg
    Direct instillation into the surgical site
    Other Name: Adlea
  • Drug: Placebo Comparator
    Direct instillation into the surgical site
  • Drug: 4975 - 5 mg
    Direct instillation into the surgical site
  • Experimental: 1
    4975 - 15 mg
    Intervention: Drug: 4975, 15 and 5 mg
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo Comparator
  • Experimental: 3
    4975 - truncated for Phase 3
    Intervention: Drug: 4975 - 5 mg
Hartrick CT, Pestano C, Carlson N, Hartrick S. Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. Clin Drug Investig. 2011 Dec 1;31(12):877-82. doi: 10.2165/11593860-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681356
114-01P
Yes
Lisa Renick, CRA, Anesiva, Inc,
Anesiva, Inc.
Not Provided
Study Director: Shaun Comfort, MD Anesiva, Inc.
Anesiva, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP