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Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
This study has been completed.
First Received: January 8, 2008   Last Updated: November 11, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:
  • Spontaneous SAE Reports. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

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).

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598559

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
Sponsors and Collaborators
Cadence Pharmaceuticals
Investigators
Principal Investigator: Eugene Viscusi, MD Thomas Jefferson University
  More Information

No publications provided

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

Keywords provided by Cadence Pharmaceuticals:
Acute pain
Fever
IV Acetaminophen
Analgesic

Additional relevant MeSH terms:
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010