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

Johnson & Johnson (J&J)

Status and phase

Withdrawn

Phase 3

Conditions

Orthodontic Pain

Treatments

Drug: Acetaminophen/Naproxen Sodium Fixed Combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT05845008

CCSPAP005204 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 16 years old

Volunteers

Accepts Healthy Volunteers

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