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

CCSPAP005204

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.

2024-01-15

2024-07-15

2024-07-26

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-03-05