A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain.

Official Title
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An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain

Conditions
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Orthodontic Pain

Intervention / Treatment
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* Drug: Acetaminophen/Naproxen Sodium Fixed Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weigh 72 pounds or greater and have a body mass index (BMI)-for-age between the 5th and 95th percentile (inclusive) at Screening Have undergone an orthodontic procedure within 4 hours prior to baseline (enrollment) visit Females of childbearing potential and males agree to the contraceptive requirements of study Exclusion Criteria: Are female and are pregnant, breastfeeding, or trying to become pregnant or male with a pregnant partner or a partner currently trying to become pregnant Have a positive urine drug test on screening or enrollment Are not able to swallow whole tablets or capsules Arrive at the site on the day of enrollment with motion sickness and/or have a history of frequent motion sickness (car sickness) in the past year, which in the judgement of the investigator is likely to confound assessment of adverse events Routinely use oral analgesics greater than or equal to (>=) 5 times per week Have a known allergy or hypersensitivity to naproxen (or other nonsteroidal anti-inflammatory drugs including aspirin) or acetaminophen or have asthma Have presence or a history of major medical condition that in the Investigator's opinion may jeopardize the participant's safety or wellbeing or the integrity of the study Have a history of chronic use of tranquilizers, alcohol, tobacco/vaping, or substance abuse, as judged by the Investigator site staff, in the last year Have a history of endoscopically documented peptic ulcer disease or bleeding disorder in the last two years Have a diagnosis of gastroesophageal reflux disorder, or experienced frequent heartburn in the past year

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen/Naproxen Sodium Fixed Combination<br>Participants will self-administer a fixed combination of acetaminophen/naproxen sodium orally as multiple doses over a period of up to 10 days. | Drug: Acetaminophen/Naproxen Sodium Fixed Combination<br>* Acetaminophen/naproxen sodium fixed combination tablets, oral.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the investigational product (IP). A TEAE is an AE that occurs after the first dose of study drug, or an AE that started before the first use of study drug and worsened after taking the study drug. | Up to Day 10 | 
| Number of Participants with Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. A SAE is an AE or suspected adverse reaction resulting in any of the following outcomes: result in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly/birth defect; is considered medically significant; is a suspected transmission of any infectious agent via a medical product. | Up to Day 10 | 
| Number of Participants with Treatment-related AEs | An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. Treatment-related AEs are adverse events evaluated by the investigator as possible, probable or very likely related to investigational product. | Up to Day 10 |