Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Cadence Pharmaceuticals |
---|---|
Information provided by: | Cadence Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00564486 |
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 APAP Drug: IV Placebo Drug: IV Acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blind Placebo-Controlled, Multi-Center, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of Intravenous Acetaminophen Versus Placebo for the Treatment of Postoperative Pain After Abdominal Laparoscopic Surgery |
Estimated Enrollment: | 240 |
Study Start Date: | November 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
IV Placebo 100ml: Placebo Comparator
IV Placebo 100ml
|
Drug: IV APAP
IV, q4 for 24 hours
|
IV Placebo 65ml: Placebo Comparator
IV Placebo 65ml
|
Drug: IV Placebo
IV, q6 for 24 hours
|
IV Acetaminophen 1gm: Experimental
IV Acetaminophen 1gm
|
Drug: IV Acetaminophen
IV, q4 for 24 hours
|
IV Acetaminophen 650mg: Experimental
IV Acetaminophen 650mg
|
Drug: IV Acetaminophen
IV, q4 for 24 hours
|
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.
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 less than/equal to 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)
United States, Alabama | |
Helen Keller Hospital | |
Sheffield, Alabama, United States, 35660 | |
United States, Arizona | |
Precision Trials | |
Phoenix, Arizona, United States, 85032 | |
United States, California | |
Huntington Memorial Hospital | |
Pasadena, California, United States, 91105 | |
Physicians Clinical Research Corporation | |
Laguna Hills, California, United States, 92653 | |
Glendale Adventist Medical Center | |
Glendale, California, United States, 91206 | |
Methodist Hospital | |
Arcadia, California, United States, 91007 | |
United States, Florida | |
Visions Clinical Research | |
Boynton Beach, Florida, United States, 33414 | |
G and G Research, Inc. | |
Fort Pierce, Florida, United States, 34950 | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
Nature Coast Clinical Research | |
Crystal River, Florida, United States, 34429 | |
Advanced Surgery Associates at Mercy Hospital | |
Miami, Florida, United States, 33133 | |
United States, Michigan | |
William Beaumont Hospital | |
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 |
Responsible Party: | Cadence Pharmaceuticals ( Mike Royal, VP Clinical Development, Analgesics ) |
Study ID Numbers: | CPI-APA-304 |
Study First Received: | November 26, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00564486 |
Health Authority: | United States: Food and Drug Administration |
Abdominal Laparoscopic Surgery |
Signs and Symptoms Postoperative Complications Pain Acetaminophen Pain, Postoperative |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |