Clinical trial NCT05845008: A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Orthodontic Pain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 10
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 10
measure: Number of Participants with Treatment-related AEs
timeFrame: Up to Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: JBR Clinical Research LLP
state: Utah
Study officials:
affiliation: JBR Clinical Research
name: Todd Bertoch
role: PRINCIPAL_INVESTIGATOR
References: