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Sponsored by: |
Cadence Pharmaceuticals |
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Information provided by: | Cadence Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00598702 |
IV APAP is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight
Condition | Intervention | Phase |
---|---|---|
Pain Fever |
Drug: IV APAP Acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients. |
Estimated Enrollment: | 70 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
IV APAP
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Drug: IV APAP Acetaminophen
o Target is 5 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
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To assess the safety of IV APAP when used over five or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are NPO, require or would benefit from IV treatment, or are willing and able to stay on IV APAP therapy for 5 to 7 days
Ages Eligible for Study: | 37 Weeks to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mike Royal, MD, JD, MBA | 858-436-1427 | mroyal@cadencepharm.com |
Contact: Lola Fong | 858-436-1438 | lfong@cadencepharm.com |
United States, California | |
Lucile Salter Packard Children's Hospital at Stanford | Recruiting |
Stanford, California, United States, 94305 | |
United States, Delaware | |
Alfred Dupont Hospital for Children | Recruiting |
Wilmington, Delaware, United States, 19803 | |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, DC, District of Columbia, United States, 20010 | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
University of Michigan Ann Arbor | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
University of Missouri | Recruiting |
Columbia, Missouri, United States, 65212 | |
United States, New York | |
Hospital for Special Surgery | Recruiting |
New York, New York, United States, 10021 | |
SUNY Stony Brook | Recruiting |
Stony Brook, New York, United States, 11794 | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Thomas Jefferson University | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Houston Neonatal-Perinatal Physicians | Recruiting |
Bellaire, Texas, United States, 77401 |
Study Director: | Mike Royal, MD, JD, MBA | Cadence Pharmaceuticals |
Responsible Party: | Cadence Pharmaceuticals ( Mike Royal MD JD MBA, VP Clinical Development, Analgesics ) |
Study ID Numbers: | CPI-APA-352 |
Study First Received: | January 9, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00598702 |
Health Authority: | United States: Food and Drug Administration |
Fever Pain Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |