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

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598559
• Other study ID #: CPI-APA-351
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2008
• Last updated: May 14, 2015
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2015
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Fever

Intervention

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.

Locations

Country	Name	City	State
United States	Arcadia Methodist Hospital	Arcadia	California
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	G&G Research	Fort Pierce	Florida
United States	Glendale Adventist Medical Center	Glendale	California
United States	Memorial Herman/Memorial City Hospital	Houston	Texas
United States	Accurate Clinical Trials, Inc.	Laguna Hills	California
United States	University of Miami School of Medicine	Miami	Florida
United States	Weill Medical College of Cornell University	New York	New York
United States	Huntington Memorial Hospital	Pasadena	California
United States	Lotus Clinical Research, Inc.	Pasadena	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Oregon Health Science University	Portland	Oregon
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).	Number of subjects who experienced at least one treatment emergent adverse event (TEAE).; A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).	T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up	Yes
Primary	Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)	Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death; is life threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event	First dose (T0) to within 30 days of the last dose of study medication.	Yes
Secondary	Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments	Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)	End of Day 5 (prior to discharge)	No
Secondary	Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.	Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.	Study period lookback at Day 7	No