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

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Fever; Acute Pain

Treatments: Drug: IV Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598559

CPI-APA-351

Details and patient eligibility

About

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.

Full 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

Enrollment: 213 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 3 patient groups

1 g IV Acetaminophen

Experimental group

Description:

1 g q6h IV Acetaminophen

Treatment:

Drug: IV Acetaminophen

650 mg IV Acetaminophen

Experimental group

Description:

650 mg q4h IV Acetaminophen

Treatment:

Drug: IV Acetaminophen

Standard of Care

Other group

Description:

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.

Treatment:

Drug: IV Acetaminophen