Phase 3
N=213
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Acute Pain · Fever
Bottom Line
View on ClinicalTrials.gov: NCT00598559 ↗Enrolled (actual)
213
Serious AEs
13.2%
Results posted
Dec 2010
Primary outcome: Primary: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). — 77; 86; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IV Acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). |
77; 86; 26 | — |
| PRIMARY Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) |
14; 11; 3 | — |
| SECONDARY Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments |
2.5; 2.5; 2.0 | — |
| SECONDARY Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period. |
2.4; 2.3; 2.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00598559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.