NCT00598559

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-01-22
• Last updated: 2016-10-21
• Results posted: 2010-12-10

Locations

14 sites across 1 country: United States