Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
This study has been terminated.
(Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.)
Sponsor:
Anesiva, Inc.
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00683267
First received: May 21, 2008
Last updated: May 1, 2009
Last verified: May 2009
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Purpose
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
| Condition | Intervention | Phase |
|---|---|---|
|
Arthroplasty |
Drug: 4975, highly purified capsaicin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty |
Resource links provided by NLM:
MedlinePlus related topics:
Hip Replacement
Drug Information available for:
Capsaicin
U.S. FDA Resources
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 endpoints, safety and tolerability of 4975 [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]
| Enrollment: | 118 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Study treatment, 4975, is instilled directly into surgical site
|
Drug: 4975, highly purified capsaicin
One dose administered by direct instillation into the surgical site
Other Name: 4975, Adlea
|
|
Placebo Comparator: 2
Placebo is instilled directly into surgical site
|
Drug: Placebo
One dose administered by direct instillation into the surgical site
|
Detailed Description:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip 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, III
- Planning to undergo unilateral THA
- In good health and capable of undergoing THA with spinal block and sedation anesthesia
- No additional planned surgeries during the course of the trial
- Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English
Key Exclusion Criteria:
- A body mass index greater than 40
- Known bleeding disorder or is taking agents affecting coagulation preoperatively
- A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
- Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
- Previous hip arthroplasty of the same hip
- Participated in another clinical trial within 30 days of the planned hip surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683267
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| United States, California | |
| Lotus Clinical Research, Inc. | |
| Arcadia, California, United States, 91007 | |
| Glendale Adventist Medical Center | |
| Glendale, California, United States, 91206 | |
| Webster Orthopaedic Medical Group | |
| Oakland, California, United States, 94612 | |
| University of California at San Francisco - Mt. Zion | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Coastal Medical Research, Inc. | |
| Port Orange, Florida, United States, 32127 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| William Beaumont Hospital | |
| Troy, Michigan, United States, 48085 | |
| United States, Pennsylvania | |
| Sewickley Valley Hospial | |
| Sewickley, Pennsylvania, United States, 15143 | |
| United States, Texas | |
| Covenant Medical Center | |
| Lubbock, Texas, United States, 79410 | |
Sponsors and Collaborators
Anesiva, Inc.
Investigators
| Study Director: | Shaun Comfort, MD, MBA | Anesiva, Inc. |
| Study Director: | William Houghton, MD | Anesiva, Inc. |
More Information
No publications provided
| Responsible Party: | Shaun Comfort, MD, Anesiva, Inc. |
| ClinicalTrials.gov Identifier: | NCT00683267 History of Changes |
| Other Study ID Numbers: | 114-03P |
| Study First Received: | May 21, 2008 |
| Last Updated: | May 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anesiva, Inc.:
|
THA, Total hip arthroplasty, total hip replacement |
Additional relevant MeSH terms:
|
Capsaicin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013