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| Sponsor: | Cadence Pharmaceuticals |
|---|---|
| Information provided by: | Cadence Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00598559 |
Purpose
The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen over five days for the treatment of acute pain or fever in adult patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Pain Fever |
Drug: IV Acetaminophen |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients |
| Estimated Enrollment: | 175 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
1g q6 IV Acetaminophen or 650g q4 IV Acetaminophen
|
Drug: IV Acetaminophen
Arm 1: 1g q6 IV Acetaminophen administered for five days. Arm 2: 650 mg q4 IV Acetaminophen administered for five days. Arm 3: Standard of Care Group (standard treatment for the treatment of pain or fever within the specific institution).
|
|
2
Standard of Care
|
Drug: IV Acetaminophen
Arm 1: 1g q6 IV Acetaminophen administered for five days. Arm 2: 650 mg q4 IV Acetaminophen administered for five days. Arm 3: Standard of Care Group (standard treatment for the treatment of pain or fever within the specific institution).
|
• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients
Secondary Objectives:
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Accurate Clinical Trials, Inc. | |
| Laguna Hills, California, United States, 92653 | |
| Arcadia Methodist Hospital | |
| Arcadia, California, United States, 91007 | |
| Glendale Adventist Medical Center | |
| Glendale, California, United States, 91206 | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91105 | |
| Santa Barbara Cottage Hospital | |
| Santa Barbara, California, United States, 93105 | |
| Lotus Clinical Research, Inc. | |
| Pasadena, California, United States, 91105 | |
| United States, Florida | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Nature Coast Clinical Research | |
| Crystal River, Florida, United States, 34429 | |
| G&G Research | |
| Fort Pierce, Florida, United States, 34950 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Memorial Herman/Memorial City Hospital | |
| Houston, Texas, United States, 77024 | |
| Principal Investigator: | Eugene Viscusi, MD | Thomas Jefferson University |
More Information
| Responsible Party: | Cadence Pharmaceuticals ( Cadence Pharmaceuticals ) |
| Study ID Numbers: | CPI-APA-351 |
| Study First Received: | January 8, 2008 |
| Last Updated: | November 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00598559 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute pain Fever IV Acetaminophen Analgesic |
|
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |