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

NCT ID: NCT05845008

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-07-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Acetaminophen/Naproxen Sodium Fixed Combination

Intervention Type: DRUG

Acetaminophen/naproxen sodium fixed combination tablets, oral.

Interventions

Acetaminophen/Naproxen Sodium Fixed Combination

Acetaminophen/naproxen sodium fixed combination tablets, oral.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Bertoch

Role: PRINCIPAL_INVESTIGATOR

JBR Clinical Research

Locations

JBR Clinical Research LLP

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

CCSPAP005204

Identifier Type: OTHER

Identifier Source: secondary_id

CCSPAP005204

Identifier Type: -

Identifier Source: org_study_id