Acute PainPhase 3NCT00598559

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

A Phase 3 study testing IV Acetaminophen in people with Acute Pain and Fever, run by Mallinckrodt at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Acute Pain, Fever
What is being tested?: IV Acetaminophen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 213 participants
Where: 14 sitesUnited States
Study dates: Jan 2008to Nov 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Arcadia Methodist Hospital
Arcadia, California, 91007
The Ohio State University Medical Center
Columbus, Ohio, 43210
Nature Coast Clinical Research
Crystal River, Florida, 34429
G&G Research
Ft. Pierce, Florida, 34950
Glendale Adventist Medical Center
Glendale, California, 91206
Memorial Herman/Memorial City Hospital
Houston, Texas, 77024
Accurate Clinical Trials, Inc.
Laguna Hills, California, 92653
University of Miami School of Medicine
Miami, Florida, 33136
Weill Medical College of Cornell University
New York, New York, 10021
Huntington Memorial Hospital
Pasadena, California, 91105
Lotus Clinical Research, Inc.
Pasadena, California, 91105
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health Science University
Portland, Oregon, 97239
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105

Other trials in United States

About this study

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

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.

Read the 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
Being tested: IV Acetaminophen
Keywords: Acute pain, Fever, IV Acetaminophen, Analgesic
Medical subject headings: Acute Pain, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV AcetaminophenDrug
Also called IV Acetaminophen (IV APAP)
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.

Study groups in NCT00598559
Study group	Role	What they receive
1 g IV Acetaminophen	Experimental	1 g q6h IV Acetaminophen Receives: Drug: IV Acetaminophen
650 mg IV Acetaminophen	Experimental	650 mg q4h IV Acetaminophen Receives: 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. Receives: Drug: IV Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 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
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)
Measured: 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.
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.
Measured: Study period lookback at Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Nov 2008

First posted22 Jan 2008 (estimated)
Study startJan 2008
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00598559
Sponsor's protocol ID: CPI-APA-351
Status last verified: Sep 2016
First submitted: 8 Jan 2008
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00598559
Acronym / sponsor ID: CPI-APA-351
Conditions: Acute Pain, Fever
Keywords: Acute pain, Fever, IV Acetaminophen, Analgesic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 22 Jan 2008 (estimated)
Results: Posted 10 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1 g IV Acetaminophen	Experimental	Drug: IV Acetaminophen1 g q6h IV Acetaminophen
650 mg IV Acetaminophen	Experimental	Drug: IV Acetaminophen650 mg q4h IV Acetaminophen
Standard of Care	Other	Drug: IV AcetaminophenThe 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV AcetaminophenAlso: IV Acetaminophen (IV APAP)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.	Drug	1 g IV Acetaminophen, 650 mg IV Acetaminophen, Standard of Care

Primary outcome

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
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).
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.
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

2 secondary outcomes

Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
Time frame: 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.
Time frame: Study period lookback at Day 7

Results and safety

Results posted to the registry on 10 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Acetaminophen 1 Gram Every 6 Hours	92	65
IV Acetaminophen 650 Milligram Every 4 Hours	91	63
Standard of Care (SOC)	30	27

Primary outcome: 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. Number. Unit: Participants

Measure	IV Acetaminophen 1 g q6h n = 92	IV Acetaminophen 650 mg q4h n = 91	Standard of Care (SOC) n = 30
Value	77	86	26

Population analysed: Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.

Primary outcome: 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.. Number. Unit: Participants

Measure	IV Acetaminophen 1 g q6h n = 92	IV Acetaminophen 650 mg q4h n = 91	Standard of Care (SOC) n = 30
Value	14	11	3

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected after the start of study medication (T0) until approximately 7 days after the last dose for IVAPAP group or 12 days from T0 for SOC group. SAEs were collected from first dose until 30 days fter the last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Acetaminophen 1 Gram Every 6 Hours	14 of 92 (15.2%)	60 of 92 (65.2%)	Not reported
IV Acetaminophen 650 Milligram Every 4 Hours	11 of 91 (12.1%)	68 of 91 (74.7%)	Not reported
Standard of Care (SOC)	3 of 30 (10%)	18 of 30 (60%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Viscusi, MD principal investigator

Thomas Jefferson University

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IV Acetaminophen in people with Acute Pain and Fever, run by Mallinckrodt at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00598559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.