Expired Study
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Laguna Hills, California 92653


Purpose:

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.


Study summary:

• 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


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


Study is Available At:


Original ID:

CPI-APA-351


NCT ID:

NCT00598559


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cadence Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

213


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eugene Viscusi, MD
Principal Investigator
Thomas Jefferson University

Study Dates

Start Date:January 2008
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:November 2008
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 11, 2010
First Received Date:January 8, 2008
First Results Date:September 25, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
Time Frame:T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up
Safety Issues:True
Description: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).
Outcome Type:Primary Outcome
Measure:Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
Time Frame:First dose (T0) to within 30 days of the last dose of study medication.
Safety Issues:True
Description:Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death is life threatening requires inpatient hopsitalization or causes prolongation of existing hospitalization results in persistent or significant disa
Outcome Type:Secondary Outcome
Measure:Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
Time Frame:End of Day 5 (prior to discharge)
Safety Issues:False
Description: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)
Outcome Type:Secondary Outcome
Measure:Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.
Time Frame:Study period lookback at Day 7
Safety Issues:False
Description: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 Interventions

Intervention Type:Drug
Name:IV Acetaminophen
Description: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.
Arm Name:1 g IV Acetaminophen
Other Name:IV Acetaminophen (IV APAP)

Study Arms

Study Arm Type:Experimental
Arm Name:1 g IV Acetaminophen
Description:1 g q6h IV Acetaminophen
Study Arm Type:Experimental
Arm Name:650 mg IV Acetaminophen
Description:650 mg q4h IV Acetaminophen
Study Arm Type:Other
Arm Name:Standard of Care
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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cadence Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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