Expired Study
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Laguna Hills, California 92653


Purpose:

The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.


Study summary:

• 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 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (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 (SOC) treatment over 5 days of treatment - To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment


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 kilogram (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., Alanine aminotransferase (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


NCT ID:

NCT00598559


Primary Contact:

Principal Investigator
Eugene Viscusi, MD
Thomas Jefferson University


Backup Contact:

N/A


Location Contact:

Laguna Hills, California 92653
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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