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

• Status: Not yet recruiting
• Trial end date: 2024-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Treatments: Acetaminophen; Naproxen

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