PainPhase 2/3NCT01328808
Metabolism and Toxicity of Acetaminophen
A Phase 2/3 study testing Acetaminophen/APAP in people with Pain, run by John van den Anker at 2 sites in United States.
Trial summary
The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or… Read more about this study
- Who is it for?
- Ages 22 to 37 weeks
- Conditions the study is for
- Pain
- What is being tested?
- Acetaminophen/APAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 22 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm and term neonates of both genders and all races
- a postnatal age of less than 28 days
- GA's of from 22 to less than 37 weeks
- an indwelling (peripheral or umbilical) arterial line
- a clinical indication for intravenous administration of pain relief medication
Who cannot join
- Neonates with severe asphyxia
- grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations (e.g., cleft lip and palate),
- neurological disorders
- those receiving continuous or intermittent neuromuscular blockers
- clinical or biochemical evidence of hepatic renal failure (including systemic hypoperfusion)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Childrens Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Metabolism and Toxicity of Acetaminophen in Preterm Infants
The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or characteristics affect how APAP is handled within the preterm infant. By taking several blood and urine samples during the study, we will be able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.
Read the detailed description
Study procedures: The decision to replace standard intravenous morphine therapy with APAP will be made by the attending neonatologist.
Length of participation: 60 hours. No patient will be prescribed the medication specifically for the study purposes in the study protocol.
- Conditions
- Pain
- Being tested
- Acetaminophen/APAP
- Keywords
- Acetaminophen, Preterm Infants
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen/APAPDrug
Also called Tylenol
In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute.
In preterm and term neonates with a GA of less than 28 weeks a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute
| Study group | Role | What they receive |
|---|---|---|
| group 2 Pain management | Experimental | In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute.
In preterm and term neonates with a GA of less than 28 weeks 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute Receives: Drug: Acetaminophen/APAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint PK analysis
Blood and urine levels of APAP and metabolites
Measured: 48 hours
Secondary outcomes (1)
Developmental stage
To assess both the magnitude and statistical significance of any evidence of relationship between developmental stage and toxicity-associated metabolite levels.
The analyses will also hold constant APAP dose, BID or TID and possible confounding variables such as birth order, maternal smoking status, and maternal age. We will plot the relationship between stage of development and measures of APAP Metabolism, taken at different gestational and postnatal ages. A hierarchical, cross sectional time series models will be used.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- John van den Anker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John van den Anker, Children's National Research Institute
- Investigators
- John N van den Anker, MD, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328808
- Sponsor's protocol ID
- 4839 - APAP
- Status last verified
- Dec 2021
- First submitted
- 30 Mar 2011
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is no plan to share individual participant data. Preliminary data published Published manuscripts in 2015 \& 2016
Publications
Cook SF, Stockmann C, Samiee-Zafarghandy S, King AD, Deutsch N, Williams EF, Wilkins DG, Sherwin CM, van den Anker JN. Neonatal Maturation of Paracetamol (Acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent-Metabolite Population Pharmacokinetic Model. Clin Pharmacokinet. 2016 Nov;55(11):1395-1411. doi: 10.1007/s40262-016-0408-1.
PubMed 27209292Cook SF, King AD, van den Anker JN, Wilkins DG. Simultaneous quantification of acetaminophen and five acetaminophen metabolites in human plasma and urine by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry: Method validation and application to a neonatal pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Dec 15;1007:30-42. doi: 10.1016/j.jchromb.2015.10.013. Epub 2015 Oct 31.
PubMed 26571452Cook SF, Roberts JK, Samiee-Zafarghandy S, Stockmann C, King AD, Deutsch N, Williams EF, Allegaert K, Wilkins DG, Sherwin CM, van den Anker JN. Population Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation. Clin Pharmacokinet. 2016 Jan;55(1):107-19. doi: 10.1007/s40262-015-0301-3.
PubMed 26201306
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Toxicity of Acetaminophen in Preterm Infants
- ClinicalTrials.gov ID
- NCT01328808
- Acronym / sponsor ID
- 4839 - APAP
- Conditions
- Pain
- Keywords
- Acetaminophen, Preterm Infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- John van den AnkerUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or characteristics affect how APAP is handled within the preterm infant. By taking several blood and urine samples during the study, we will be able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.
Detailed description
Study procedures: The decision to replace standard intravenous morphine therapy with APAP will be made by the attending neonatologist.
Length of participation: 60 hours. No patient will be prescribed the medication specifically for the study purposes in the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 2 Pain management | Experimental | Drug: Acetaminophen/APAPIn preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute |
Who may qualify
- Ages
- 22 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm and term neonates of both genders and all races
- a postnatal age of less than 28 days
- GA's of from 22 to less than 37 weeks
- an indwelling (peripheral or umbilical) arterial line
- a clinical indication for intravenous administration of pain relief medication
Key exclusion criteria (5 listed)
- Neonates with severe asphyxia
- grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations (e.g., cleft lip and palate),
- neurological disorders
- those receiving continuous or intermittent neuromuscular blockers
- clinical or biochemical evidence of hepatic renal failure (including systemic hypoperfusion)
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 |
|---|---|---|
| Acetaminophen/APAPAlso: TylenolIn preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute | Drug | group 2 Pain management |
Primary outcome
primary endpoint PK analysis
Time frame: 48 hours
Blood and urine levels of APAP and metabolites
1 secondary outcome
Developmental stage
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Results publication: PubMed 27209292Cook SF, Stockmann C, Samiee-Zafarghandy S, King AD, Deutsch N, Williams EF, Wilkins DG, Sherwin CM, van den Anker JN. Neonatal Maturation of Paracetamol (Acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent-Metabolite Population Pharmacokinetic Model. Clin Pharmacokinet. 2016 Nov;55(11):1395-1411. doi: 10.1007/s40262-016-0408-1.
- Results publication: PubMed 26571452Cook SF, King AD, van den Anker JN, Wilkins DG. Simultaneous quantification of acetaminophen and five acetaminophen metabolites in human plasma and urine by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry: Method validation and application to a neonatal pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Dec 15;1007:30-42. doi: 10.1016/j.jchromb.2015.10.013. Epub 2015 Oct 31.
- Results publication: PubMed 26201306Cook SF, Roberts JK, Samiee-Zafarghandy S, Stockmann C, King AD, Deutsch N, Williams EF, Allegaert K, Wilkins DG, Sherwin CM, van den Anker JN. Population Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation. Clin Pharmacokinet. 2016 Jan;55(1):107-19. doi: 10.1007/s40262-015-0301-3.
- Individual participant dataSharing planned: Yes. There is no plan to share individual participant data. Preliminary data published Published manuscripts in 2015 \& 2016
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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.
John N van den Anker, MD, PhD principal investigator
Children's National Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acetaminophen/APAP in people with Pain, run by John van den Anker at 2 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 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
primary endpoint PK analysis (time frame: 48 hours). 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 NCT01328808, which also lists 3 linked publications.
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 2 Mar 2022.