Orthodontic PainPhase 1NCT05844995

A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain

A Phase 1 study testing Acetaminophen/Naproxen Sodium in people with Orthodontic Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Orthodontic Pain
What is being tested?: Acetaminophen/Naproxen Sodium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2023to 14 Feb 2024
Phase: Phase 1
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 12 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A parent or a legal guardian of the participant has signed and dated the informed consent document and a written assent has been signed by the participant
Has undergone an orthodontic procedure within 72 hours prior to dosing
Is otherwise a healthy adolescent between the ages of 12 to less than (<) 17 years at baseline (dosing). Health is defined as the absence of clinically relevant abnormalities as judged by the principle investigator (PI) on the basis of a detailed medical history, physical examination, blood pressure, respiratory rate and pulse rate measurements, and clinical laboratory tests. The responsible PI may request additional investigations or analyses if necessary
Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
Has been fasted for at least 10 hours prior to dose administration of the investigational product
Is a non-tobacco user or previous user who completely stopped smoking or using any form of tobacco or nicotine-containing product [including e-cigarettes, cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (such as dip, snuff, snus, and chewing tobacco)] for at least 12 months before screening visit of this study

Show all 10Show fewer

If female, have a negative test for pregnancy at screening and baseline (dosing)
Females of childbearing potential and males agree to the contraceptive requirements
Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol
Are willing for investigational product of this study to be the only analgesic product used during the study

Who cannot join

Use of prescription or non-prescription medications within a period less than 5 half-lives before the first investigational product (IP) administration unless these are contraceptives or occasional use of other medications approved by the Investigator
Use of Ibuprofen within 6 hours prior to the dose administration of the investigational product
Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug
Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatory drug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
If female, has a positive pregnancy test or is breast-feeding or currently trying to become pregnant
Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)

Show all 20Show fewer

Has a positive test for drugs of abuse at screening or baseline (dosing)
Has difficult venipuncture access and/or refuses to undergo venipuncture
Has clinically significant renal or hepatic impairment according to the medically qualified Investigator discretion, or presence of a disease, which in the opinion of the Investigator, would preclude the use of IP
Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease, or any other active inflammatory disease of the gastrointestinal tract such as ulcerative colitis or crohn's disease), or has a history of gastrointestinal surgery (including cholecystectomy) that would affect the pharmacokinetic (PK) assessment of the drug or the safety of the participant
Has history of substance abuse, as judged by the PI, within 12 months preceding this study
Has used alcohol within 24 hours of baseline visit and/or has positive alcohol test in expired air at screening or baseline visit
Has used food or beverages containing xanthines (that is, tea, coffee, cola drinks, energy drinks or chocolate) for 48 hours prior to the dosing and during the study period
Has used grapefruit and savoy oranges for 48 hours prior to the dosing and during the study period
Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the dose of study drug
Has preplanned surgery, procedures, or personal commitments that would interfere with the conduct of the study
Had an acute blood loss of 50 milliliter (mL) to 249 mL within the 30 days, or 250 mL to 449 mL within the 45 days, or greater than or equal to (>=) 450 mL within the 60 days before first dose administration
Has any acute or chronic medical or psychiatric condition(s) that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified Investigator, would make the participant inappropriate for entry into this study
Has any clinically important abnormal value for serum chemistry, hematology, or urinalysis at screening. Laboratory values will generally be within the normal ranges, although minor deviations in tests (except those explicitly specified in the inclusion criteria) that are not considered clinically important by the Investigator are acceptable
Is related to persons involved directly or indirectly with the conduct of the study (that is, principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the Sponsor or Johnson \& Johnson (J\&J) subsidiaries, and the family of each)

Trial locations and contacts

1 site in 1 country.

United States1 site

JBR Clinical Research LLP
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: An Open-label, Single-dose, Pharmacokinetic Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Orthodontic Pain

The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to <17 years of age with post-procedure orthodontic pain.

Conditions: Orthodontic Pain
Being tested: Acetaminophen/Naproxen Sodium

What participants receive

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

Acetaminophen/Naproxen SodiumDrug
Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.

Study groups in NCT05844995
Study group	Role	What they receive
Acetaminophen /Naproxen Sodium	Experimental	Participants with age group 12 to less than (<) 17 years who undergone a non-surgical orthodontic procedure will enroll and receive fixed dose combination of acetaminophen/naproxen sodium tablet orally on baseline (Day 0). Receives: Drug: Acetaminophen/Naproxen Sodium

What is being measured

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

Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium
CL/F is defined as apparent clearance of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Apparent Central Volume of Distribution (Vc/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Vc/F is defined as apparent central volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Apparent Peripheral Volume of Distribution (Vp/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Vp/F is defined as apparent peripheral volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Apparent Inter-compartmental Clearance (Q/F) of Acetaminophen/Naproxen Sodium
Q/F is defined as apparent inter-compartmental clearance of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
First-order Absorption Rate Constant (Ka) of Acetaminophen/Naproxen Sodium
Ka is defined as first-order absorption rate constant of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Maximum Plasma Concentration (Cmax) of Acetaminophen/Naproxen Sodium
Cmax is defined as maximum plasma concentration of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Time of occurrence of Maximum Plasma Concentration (Tmax) of Acetaminophen/Naproxen Sodium
Tmax is defined as time of occurrence of maximum plasma concentration of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Area Under the Plasma Concentration versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable Plasma Concentration (AUC[0-t])
AUC(0-t) is defined as area under the plasma concentration versus time curve from start of drug administration until the time of the last measurable plasma concentration of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Area Under the Plasma Concentration versus Time Curve From Start of Drug Administration Until Infinity (AUC[0-infinite])
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from start of drug administration until infinity of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Terminal Elimination Rate Constant (lambda[z]) of Acetaminophen/Naproxen Sodium
Lambda(z) is defined as terminal elimination rate constant of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose
Half Life (t1/2) of Acetaminophen/Naproxen Sodium
T1/2 is defined as half life of acetaminophen/naproxen sodium.
Measured: Pre-dose up to 48 hours post dose

Secondary outcomes (1)

Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence that occurs in participants after they have signed an informed consent for the study. The event does not need to have a suspected causal relationship with the investigational product (IP).
Measured: Up to 3 days

Timeline

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

13 Sep 202314 Feb 2024

First posted6 May 2023
Study start13 Sep 2023
Primary completion12 Feb 2024
Study completion14 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (47)Papers the sponsor has linked to this study.
Other trials for Orthodontic 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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05844995
Sponsor's protocol ID: CCSPAP005203
Other IDs: CCSPAP005203
Status last verified: Mar 2024
First submitted: 25 Apr 2023
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Publications

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714
GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
PubMed 14191090
LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
PubMed 14248351
Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
PubMed 16413237
Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
PubMed 16580905
Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
PubMed 18485596
McGilveray IJ, Mattok GL, Fooks JR, et al. Acetaminophen II: A comparison of the physiological availabilities of different commercial dosage forms. Can J Pharmaceut Sci 1971;6:38-42.
Liu DJ, Collaku A, Youngberg SP. Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation. Int J Clin Pharmacol Ther. 2015 Feb;53(2):172-81. doi: 10.5414/CP202146.
PubMed 25500485
Paracetamol. In: Sweetman S, ed. Martindale - The Complete Drug Reference. London, UK: The Pharmaceutical Press. 37th ed. 2011:76-79.
Grosser T, Smyth E, FitzGerald. Anti-Inflammatory, Antipyretic, and Analgesic Agents; Pharmacotherapy of Gout. In: Goodman LS, Brunton LL, Chabner B, Knollman BC. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, McGraw-Hill. 2011:959- 1004.
McNeil Consumer & Specialty Pharmaceuticals Clinical Pharmacology Report for Protocol 02- 161: Tolerability and multiple-dose pharmacokinetics of acetaminophen (paracetamol) at and above the currently recommended dose. Fort Washington, PA. McNeil Consumer & Specialty Pharmaceuticals Company. Aug 2005.
McNeil Consumer Products Company Statistical Report 7: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. Fort Washington, PA. McNeil Consumer Products Company. Dec 1978. [Meta-Analysis Code P00102]
McNeil Consumer Products Company Statistical Report 65 for Protocol 0-220: A double-blind multiple-dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Fort Washington, PA. McNeil Consumer Products Company. Jun 1986. [Meta-Analysis Code P80220]
McNeil Protocol 2-227 Data Listings. A double-blind study of the comparative antipyretic effectiveness and safety of a single 15 mg/kg, 30 mg/kg or 40 mg/kg dose of acetaminophen. Oct 1982 [Meta-Analysis Code P82227]
McNeil Consumer Products Company Report for Protocol 93-308: Pharmacokinetic and pharmacodynamic modeling of acetaminophen in febrile children: Evaluation of three products. Fort Washington, PA. McNeil Consumer Products Company. 1994. [Meta-Analysis Code P93308]

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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All Orthodontic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose, Pharmacokinetic Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Orthodontic Pain
ClinicalTrials.gov ID: NCT05844995
Acronym / sponsor ID: CCSPAP005203
Conditions: Orthodontic Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 13 Sep 2023 (actual)
Primary completion: 12 Feb 2024 (actual)
Study completion: 14 Feb 2024 (actual)
First posted: 6 May 2023 (actual)
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.

Study design

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

Arm	Type	Receives
Acetaminophen /Naproxen Sodium	Experimental	Drug: Acetaminophen/Naproxen SodiumParticipants with age group 12 to less than (<) 17 years who undergone a non-surgical orthodontic procedure will enroll and receive fixed dose combination of acetaminophen/naproxen sodium tablet orally on baseline (Day 0).

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (10 listed)

A parent or a legal guardian of the participant has signed and dated the informed consent document and a written assent has been signed by the participant
Has undergone an orthodontic procedure within 72 hours prior to dosing
Is otherwise a healthy adolescent between the ages of 12 to less than (<) 17 years at baseline (dosing). Health is defined as the absence of clinically relevant abnormalities as judged by the principle investigator (PI) on the basis of a detailed medical history, physical examination, blood pressure, respiratory rate and pulse rate measurements, and clinical laboratory tests. The responsible PI may request additional investigations or analyses if necessary
Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
Has been fasted for at least 10 hours prior to dose administration of the investigational product

Key exclusion criteria (20 listed)

Use of prescription or non-prescription medications within a period less than 5 half-lives before the first investigational product (IP) administration unless these are contraceptives or occasional use of other medications approved by the Investigator
Use of Ibuprofen within 6 hours prior to the dose administration of the investigational product
Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug
Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatory drug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
If female, has a positive pregnancy test or is breast-feeding or currently trying to become pregnant

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/Naproxen SodiumFixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.	Drug	Acetaminophen /Naproxen Sodium

Primary outcome

Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
CL/F is defined as apparent clearance of acetaminophen/naproxen sodium.
Apparent Central Volume of Distribution (Vc/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Vc/F is defined as apparent central volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Apparent Peripheral Volume of Distribution (Vp/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Vp/F is defined as apparent peripheral volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Apparent Inter-compartmental Clearance (Q/F) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Q/F is defined as apparent inter-compartmental clearance of acetaminophen/naproxen sodium.
First-order Absorption Rate Constant (Ka) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Ka is defined as first-order absorption rate constant of acetaminophen/naproxen sodium.
Maximum Plasma Concentration (Cmax) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Cmax is defined as maximum plasma concentration of acetaminophen/naproxen sodium.
Time of occurrence of Maximum Plasma Concentration (Tmax) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Tmax is defined as time of occurrence of maximum plasma concentration of acetaminophen/naproxen sodium.
Area Under the Plasma Concentration versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable Plasma Concentration (AUC[0-t])
Time frame: Pre-dose up to 48 hours post dose
AUC(0-t) is defined as area under the plasma concentration versus time curve from start of drug administration until the time of the last measurable plasma concentration of acetaminophen/naproxen sodium.
Area Under the Plasma Concentration versus Time Curve From Start of Drug Administration Until Infinity (AUC[0-infinite])
Time frame: Pre-dose up to 48 hours post dose
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from start of drug administration until infinity of acetaminophen/naproxen sodium.
Terminal Elimination Rate Constant (lambda[z]) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
Lambda(z) is defined as terminal elimination rate constant of acetaminophen/naproxen sodium.
Half Life (t1/2) of Acetaminophen/Naproxen Sodium
Time frame: Pre-dose up to 48 hours post dose
T1/2 is defined as half life of acetaminophen/naproxen sodium.

1 secondary outcome

Number of Participants with Adverse Events (AEs)
Time frame: Up to 3 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Background: PubMed 14191090GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
Background: PubMed 14248351LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
Background: PubMed 16413237Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
Background: PubMed 16580905Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
Background: PubMed 18485596Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
BackgroundMcGilveray IJ, Mattok GL, Fooks JR, et al. Acetaminophen II: A comparison of the physiological availabilities of different commercial dosage forms. Can J Pharmaceut Sci 1971;6:38-42.
Background: PubMed 25500485Liu DJ, Collaku A, Youngberg SP. Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation. Int J Clin Pharmacol Ther. 2015 Feb;53(2):172-81. doi: 10.5414/CP202146.
BackgroundParacetamol. In: Sweetman S, ed. Martindale - The Complete Drug Reference. London, UK: The Pharmaceutical Press. 37th ed. 2011:76-79.
BackgroundGrosser T, Smyth E, FitzGerald. Anti-Inflammatory, Antipyretic, and Analgesic Agents; Pharmacotherapy of Gout. In: Goodman LS, Brunton LL, Chabner B, Knollman BC. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, McGraw-Hill. 2011:959- 1004.
BackgroundMcNeil Consumer & Specialty Pharmaceuticals Clinical Pharmacology Report for Protocol 02- 161: Tolerability and multiple-dose pharmacokinetics of acetaminophen (paracetamol) at and above the currently recommended dose. Fort Washington, PA. McNeil Consumer & Specialty Pharmaceuticals Company. Aug 2005.
BackgroundMcNeil Consumer Products Company Statistical Report 7: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. Fort Washington, PA. McNeil Consumer Products Company. Dec 1978. [Meta-Analysis Code P00102]
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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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.

Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial study director

Johnson & Johnson Consumer Inc. (J&JCI)

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Acetaminophen/Naproxen Sodium in people with Orthodontic Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site 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 10 inclusion and 20 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium (time frame: Pre-dose up to 48 hours post dose). The study lists 11 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 NCT05844995, which also lists 47 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 15 Mar 2024.