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

WithdrawnPhase 3

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Conditions: Orthodontic Pain

Interventions: Acetaminophen/Naproxen Sodium Fixed Combination

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 16 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Salt Lake City, Utah, United States