PainPhase 3NCT00598702

Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

A Phase 3 study testing IV Acetaminophen in people with 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

Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight Read more about this study

Who is it for?: Ages 37 weeks to 16 years
Conditions the study is for: 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: 100 participants
Where: 14 sitesUnited States
Study dates: Jan 2008to Jan 2009
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 37 weeks to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study.
Be less than 17 years of age and older than 37 weeks post conception
Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever
Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion)
If a female of child bearing potential, have a negative pregnancy test

Who cannot join

Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV 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 the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure
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

University of Michigan Ann Arbor
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
Houston Neonatal-Perinatal Physicians
Bellaire, Texas, 77401
University of Missouri
Columbia, Missouri, 65212
Baylor College of Medicine
Houston, Texas, 77030
Hospital for Special Surgery
New York, New York, 10021
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, 94305
SUNY Stony Brook
Stony Brook, New York, 11794
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred Dupont Hospital for Children
Wilmington, Delaware, 19803

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About this study

Official title: A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.

Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight

Read the detailed description

To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.

Conditions: Pain, Fever
Being tested: IV Acetaminophen
Medical subject headings: 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 APAP, APAP
Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose

Study groups in NCT00598702
Study group	Role	What they receive
IV Acetaminophen	Experimental	40 to 75 mg/kg/day every 4 to 6 hours 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)
A TEAE is defined as an adverse event that starts on or after the start of study medication.
Measured: First dose to end of treatment period
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP 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 to 30 days after last dose

Secondary outcomes (2)

Subject's (Parent/Guardian) Global Evaluation of Study Treatment
Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).
Measured: Day 0 to Day 5, Day 7 or Early Termination from study
Physician's Global Assessment of Study Treatment
Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).
Measured: End of study or Early Termination

Timeline

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

Jan 2008Jan 2009

First posted22 Jan 2008 (estimated)
Study startJan 2008
Primary completionDec 2008
Study completionJan 2009

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 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00598702
Sponsor's protocol ID: CPI-APA-352
Status last verified: Apr 2017
First submitted: 9 Jan 2008
Last updated: 10 May 2017
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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2017. 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, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.
ClinicalTrials.gov ID: NCT00598702
Acronym / sponsor ID: CPI-APA-352
Conditions: Pain, Fever
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 22 Jan 2008 (estimated)
Results: Posted 6 Jan 2011

Clinical summary

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

Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IV Acetaminophen	Experimental	Drug: IV Acetaminophen40 to 75 mg/kg/day every 4 to 6 hours

Who may qualify

Ages: 37 weeks to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study.
Be less than 17 years of age and older than 37 weeks post conception
Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever
Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion)
If a female of child bearing potential, have a negative pregnancy test

Key exclusion criteria (4 listed)

Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV 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 the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure
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 APAP, APAPTarget is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose	Drug	IV Acetaminophen

Primary outcome

Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: First dose to end of treatment period
A TEAE is defined as an adverse event that starts on or after the start of study medication.
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
Time frame: First dose to 30 days after last dose
A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP 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's (Parent/Guardian) Global Evaluation of Study Treatment
Time frame: Day 0 to Day 5, Day 7 or Early Termination from study
Physician's Global Assessment of Study Treatment
Time frame: End of study or Early Termination

Results and safety

Results posted to the registry on 6 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h	1	1
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h	3	1
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h	7	5
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h	33	25
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h	9	6
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h	42	30
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h	1	0
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h	4	4

Primary outcome: Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)

Time frame: First dose to end of treatment period. Number. Unit: Subjects

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n = 1	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n = 3	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n = 7	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n = 33	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n = 9	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n = 42	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n = 1	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n = 4
Value	1	1	5	25	9	35	0	2

Population analysed: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

Primary outcome: Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event

Time frame: First dose to 30 days after last dose. Number. Unit: Subjects

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n = 1	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n = 3	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n = 7	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n = 33	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n = 9	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n = 42	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n = 1	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n = 4
Value	1	1	0	13	2	3	0	1

Population analysed: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h	1 of 1 (100%)	1 of 1 (100%)	Not reported
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h	1 of 3 (33.3%)	1 of 3 (33.3%)	Not reported
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h	13 of 33 (39.4%)	24 of 33 (72.7%)	Not reported
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h	3 of 42 (7.1%)	33 of 42 (78.6%)	Not reported
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h	0 of 1 (0%)	0 of 1 (0%)	Not reported
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h	1 of 4 (25%)	2 of 4 (50%)	Not reported

Limitations and caveats (from the sponsor): The original protocol required 50 subjects that completed 5 days of treatment. With protocol amendment 2, the criteria for enrollment/completion was reduced to 1 day of treatment. Subjects were required to have a minimum of 3 IV APAP doses per day.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 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 5 inclusion and 4 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 10 May 2017. 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 6 Jan 2011). 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: First dose to end of treatment period). 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 NCT00598702.

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 10 May 2017.