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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Orthodontic Pain
• Intervention / Treatment: Drug: Acetaminophen/Naproxen Sodium Fixed Combination

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Customer Call Center; Phone Number: 888-532-5849; Email: RA-CPCUS-CCCMRCSStud@ITS.JNJ.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen/Naproxen Sodium Fixed Combination; 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; Acetaminophen/naproxen sodium fixed combination tablets, oral.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Todd Bertoch, JBR Clinical Research

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 26, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Gout Suppressants; Acetaminophen; Naproxen
• Other Study ID Numbers: CCSPAP005204 (Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No