Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
Information source: Cadence Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain; Fever
Intervention: IV Acetaminophen (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Cadence Pharmaceuticals Official(s) and/or principal investigator(s):
Eugene Viscusi, MD, Principal Investigator, Affiliation: Thomas Jefferson University
Overall contact:
Mike Royal, MD, JD, MBA, Phone: 858-436-1427, Email: mroyal@cadencepharm.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Spontaneous SAE Reports.
Detailed description:
• 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:
- To compare the efficacy of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days
of treatment
- To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days
of treatment
- To compare the safety of IV Acetaminophen vs. standard of care treatment over 5 days of
treatment
- To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days
of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provide written informed consent prior to participation in the Study
- Be at least 18 years of age and weigh at least 41 kg
- Be anticipated by the Investigator to require multi-day (target is five days) use of
IV treatment either because of having a "nothing by mouth" (NPO) status having a
medical condition that makes oral intake difficult having a medical condition that
requires IV treatment
- Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment of
pain or fever (defined as a core temperature greater than or equal to 38 degrees
celsius). Note that Subjects have a slightly less than 15% chance (one in seven) of
being assigned to the Control Group and receiving standard of care treatment, but no
IV APAP.
- Have the ability to read and understand the Study procedures and have the ability to
communicate meaningfully with the Study Investigator and staff
- If a female of child bearing potential, have a negative pregnancy test within 48 hours
of randomization
Exclusion Criteria:
- Has a significant medical disease, laboratory abnormality or condition that, in the
Investigator's judgment, could compromise the Subject's welfare or would otherwise
contraindicate Study participation
- Is expected to have difficulty in communicating with the Study staff or completing
Study requirements (including follow up visits)
- Has known hypersensitivity to acetaminophen or the inactive ingredients (excipients)
of IV acetaminophen or any contraindication to receiving acetaminophen
- Has impaired liver function, e. g., ALT greater than or equal to 3 times the upper
limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active
hepatic disease (e. g., hepatitis), evidence of clinically significant chronic liver
disease or other condition affecting the liver (e. g., alcoholism as defined by DSM-IV,
cirrhosis or chronic hepatitis)
- Has participated in an interventional clinical Study (investigational or marketed
product) within 30 days of Study entry
Locations and Contacts
Mike Royal, MD, JD, MBA, Phone: 858-436-1427, Email: mroyal@cadencepharm.com
Accurate Clinical Trials, Inc., Laguna Hills, California 92653, United States; Recruiting
Kevin R. Jones, MD, Principal Investigator
Arcadia Methodist Hospital, Arcadia, California 91007, United States; Recruiting
Neil K. Singla, MD, Principal Investigator
Glendale Adventist Medical Center, Glendale, California 91206, United States; Recruiting
Sonia Singla, MD, Principal Investigator
Huntington Memorial Hospital, Pasadena, California 91105, United States; Recruiting
Neil Singla, MD, Principal Investigator
Santa Barbara Cottage Hospital, Santa Barbara, California 93105, United States; Recruiting
Kenneth S Waxman, MD, FACS, Principal Investigator
Lotus Clinical Research, Inc., Pasadena, California 91105, United States; Recruiting
Vaibhav M Anvekar, MD, Principal Investigator
University of Miami School of Medicine, Miami, Florida 33136, United States; Recruiting
Keith Candiotti, MD, Principal Investigator
Nature Coast Clinical Research, Crystal River, Florida 34429, United States; Recruiting
Laurence Ferber, MD, Principal Investigator
G&G Research, Fort Pierce, Florida 34950, United States; Active, not recruiting
Weill Medical College of Cornell University, New York, New York 10021, United States; Recruiting
Hugh Hemmings, MD, Principal Investigator
The Ohio State University Medical Center, Columbus, Ohio 43210, United States; Recruiting
Sergio Bergese, MD, Principal Investigator
Oregon Health Science University, Portland, Oregon 97239, United States; Recruiting
Julio Gonzalez-Sotomayor, MD, Principal Investigator
Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Eugene Viscusi, MD, Principal Investigator
Memorial Herman/Memorial City Hospital, Houston, Texas 77024, United States; Recruiting
Harold Minkowitz, MD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: July 2008
Last updated: July 11, 2008
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