A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Withdrawn before enrolling · Phase 3
Conditions studied: Orthodontic Pain
In brief
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.
Key facts
- Study ID
- NCT05845008
- Run by
- Johnson & Johnson Consumer Inc. (J&JCI)
- People needed
- 0
- Starts
- 2024-01-15
- Expected to finish
- 2024-07-26
- Last updated by the study team
- 2024-03-05
Who can join
Age: 12 and older, up to 16. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- JBR Clinical Research LLP — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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