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

NCT00598559 | Completed Phase 3 Results

• 1 other identifier: CPI-APA-351
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 14

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.

Conditions

Acute Pain; Fever

Keywords

Acute pain; Fever; IV Acetaminophen; Analgesic

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Secondary Outcomes (2)

• Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments

  End of Day 5 (prior to discharge)

• Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.

  Study period lookback at Day 7

Study Arms (3)

1 g IV Acetaminophen

EXPERIMENTAL

1 g q6h IV Acetaminophen

Drug: IV Acetaminophen

650 mg IV Acetaminophen

EXPERIMENTAL

650 mg q4h IV Acetaminophen

Drug: IV Acetaminophen

Standard of Care

OTHER

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.

Drug: IV Acetaminophen

Interventions

IV Acetaminophen 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.

Also known as: IV Acetaminophen (IV APAP)

1 g IV Acetaminophen; 650 mg IV Acetaminophen; Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (14)

Arcadia Methodist Hospital

Arcadia, California, 91007, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Accurate Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Lotus Clinical Research, Inc.

Pasadena, California, 91105, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

G&G Research

Ft. Pierce, Florida, 34950, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Memorial Herman/Memorial City Hospital

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Acute Pain; Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

No separate efficacy analyses were performed for the fever because only 1 subject in each active group had fever as an indication, and no subject had both pain and fever as indications for treatment with IV acetaminophen.

Results Point of Contact

• Title: Lawrence Hill
• Organization: Mallinckrodt Pharmaceuticals

lawrence.hill@mallinckrodt.com

908-238-6370

Study Officials

• Eugene Viscusi, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 22, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 21, 2016
• Results First Posted: December 10, 2010

Record last verified: 2016-09

Locations

US (14)