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

NCT05845008 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CCSPAP005204
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Acetaminophen/Naproxen Sodium Fixed Combination

EXPERIMENTAL

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

Interventions

Acetaminophen/Naproxen Sodium Fixed Combination DRUG

Acetaminophen/naproxen sodium fixed combination tablets, oral.

Acetaminophen/Naproxen Sodium Fixed Combination

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

JBR Clinical Research LLP

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Todd Bertoch

  JBR Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 26, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)