Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients

NCT ID: NCT00598559

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-11-30

Brief Summary

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.

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 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

Conditions

Acute Pain; Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 g IV Acetaminophen

1 g q6h IV Acetaminophen

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

650 mg IV Acetaminophen

650 mg q4h IV Acetaminophen

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Standard of Care

The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Group Type: OTHER

IV Acetaminophen

Intervention Type: DRUG

Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Interventions

IV Acetaminophen

Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Intervention Type: DRUG

Other Intervention Names

IV Acetaminophen (IV APAP)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Viscusi, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Arcadia Methodist Hospital

Arcadia, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Accurate Clinical Trials, Inc.

Laguna Hills, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Lotus Clinical Research, Inc.

Pasadena, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Nature Coast Clinical Research

Crystal River, Florida, United States

G&G Research

Ft. Pierce, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

Weill Medical College of Cornell University

New York, New York, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Oregon Health Science University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Memorial Herman/Memorial City Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

CPI-APA-351

Identifier Type: -

Identifier Source: org_study_id