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| Sponsor: | Cadence Pharmaceuticals |
|---|---|
| Information provided by: | Cadence Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00564486 |
Purpose
This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: IV Placebo Drug: IV Acetaminophen |
Phase III |
| 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: | Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain |
Number of subjects who experienced at least one treatment emergent adverse event (TEAE).
A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
The number of subjects who reported at least one treatment emergent SAE during the study.
A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:
| Enrollment: | 244 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: IV Placebo 100 ml
IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
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Drug: IV Placebo
IV, every 6 hours for 24 hours (4 doses total)
Other Name: placebo
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Placebo Comparator: IV Placebo 65 ml
IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
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Drug: IV Placebo
IV, every 4 hours for 24 hours (6 doses total)
Other Name: placebo
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Experimental: IV Acetaminophen 1 gm
IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
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Drug: IV Acetaminophen
IV, every 6 hours for 24 hours (4 doses total)
Other Names:
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Experimental: IV Acetaminophen 650 mg
IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
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Drug: IV Acetaminophen
IV, every 4 hours for 24 hours (6 doses total)
Other Names:
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To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Post Operative Exclusion Criteria
The Subject must not meet any of the following criteria prior to randomization to Study Medication:
Post Operative Day 1 Randomization Criterion On the morning of the first post operative day (POD1), the Subject must have a categorical pain intensity score at rest of moderate or severe and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)
Contacts and Locations| United States, Alabama | |
| Helen Keller Hospital | |
| Sheffield, Alabama, United States, 35660 | |
| United States, Arizona | |
| Precision Trials | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| Methodist Hospital | |
| Arcadia, California, United States, 91007 | |
| Glendale Adventist Medical Center | |
| Glendale, California, United States, 91206 | |
| Physicians Clinical Research Corporation | |
| Laguna Hills, California, United States, 92653 | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91105 | |
| United States, Florida | |
| Visions Clinical Research | |
| Boynton Beach, Florida, United States, 33414 | |
| Nature Coast Clinical Research | |
| Crystal River, Florida, United States, 34429 | |
| G and G Research, Inc. | |
| Fort Pierce, Florida, United States, 34950 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Advanced Surgery Associates at Mercy Hospital | |
| Miami, Florida, United States, 33133 | |
| United States, Michigan | |
| William Beaumont Hospital (Royal Oak) | |
| Royal Oak, Michigan, United States, 48073 | |
| William Beaumont Hospital (Troy) | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| United States, Texas | |
| Texas Woman's Hospital | |
| Houston, Texas, United States, 77024 | |
| Memorial Herman/Memorial City Hospital | |
| Houston, Texas, United States, 77024 | |
| Study Director: | Mike Royal, MD, JD, MBA | Cadence Pharmaceuticals |
More Information
| Responsible Party: | Mike Royal, VP Clinical Development, Analgesics, Cadence Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00564486 History of Changes |
| Other Study ID Numbers: | CPI-APA-304 |
| Study First Received: | November 26, 2007 |
| Results First Received: | September 25, 2009 |
| Last Updated: | October 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Abdominal Laparoscopic Surgery |
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Acetaminophen Analgesics Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |