Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
This study has been completed.
Sponsor:
Anesiva, Inc.
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00681356
First received: May 16, 2008
Last updated: May 1, 2009
Last verified: May 2009
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Purpose
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
| Condition | Intervention | Phase |
|---|---|---|
|
Total Knee Arthroplasty (Replacement) |
Drug: 4975, 15 and 5 mg Drug: Placebo Comparator Drug: 4975 - 5 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Anesiva, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Other efficacy parameters, safety and tolerability of 4975 [ Time Frame: 42 Days or Early Termination ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 214 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
4975 - 15 mg
|
Drug: 4975, 15 and 5 mg
Direct instillation into the surgical site
Other Name: Adlea
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo Comparator
Direct instillation into the surgical site
|
|
Experimental: 3
4975 - truncated for Phase 3
|
Drug: 4975 - 5 mg
Direct instillation into the surgical site
|
Detailed Description:
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681356
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| Springhill Medical Center | |
| Mobile, Alabama, United States, 36608 | |
| Hellen Keller Hospital | |
| Sheffield, Alabama, United States, 35660 | |
| United States, Arizona | |
| Visions Clinical Research/Tucson Medical Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Glendale Adventist Medical Center - Lotus Clinical Research | |
| Glendale, California, United States, 91206 | |
| Saddleback Memorial Medical Center/Accurate Clinical Trials | |
| Laguna Hills, California, United States, 92653 | |
| Physicians Clinical Research Corporation | |
| Laguna Hills, California, United States, 92653 | |
| Webster Orthopeadic Medical Group | |
| Oakland, California, United States, 94612 | |
| UCSF-Mt. Zion Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Orthopedic Associates of Hartford | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Florida | |
| Florida Hospital - Florida Research Associates, LLC | |
| DeLand, Florida, United States, 32720 | |
| Miami Institute for Medical Research | |
| Miami, Florida, United States, 33186 | |
| University of Miami, Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Southeastern Clinical Research Consultants | |
| Orlando, Florida, United States, 32804 | |
| Coastal Medical Research | |
| Port Orange, Florida, United States, 32127 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Ruxton Professional Center - Orthopaedic Associates | |
| Towson, Maryland, United States, 21204 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48085 | |
| William Beaumont Hospital | |
| Troy, Michigan, United States, 48085 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Sewickley Valley Hospital | |
| Sewickley, Pennsylvania, United States, 15143 | |
| United States, Texas | |
| Presbyterian Hospital of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Memorial City Hospital - Memorial Hermann Healthcare System | |
| Houston, Texas, United States, 77024 | |
Sponsors and Collaborators
Anesiva, Inc.
Investigators
| Study Director: | Shaun Comfort, MD | Anesiva, Inc. |
More Information
No publications provided by Anesiva, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lisa Renick, CRA, Anesiva, Inc, |
| ClinicalTrials.gov Identifier: | NCT00681356 History of Changes |
| Other Study ID Numbers: | 114-01P |
| Study First Received: | May 16, 2008 |
| Last Updated: | May 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anesiva, Inc.:
|
TKA Total knee arthroplasty Total knee replacement Knee surgery |
ClinicalTrials.gov processed this record on May 23, 2013