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Nonsteroidal Anti-inflammatory Drug (NSAID)

Acetaminophen/Naproxen Combo for Orthodontic Pain

Phase 3
Waitlist Available
Led By Todd Bertoch
Research Sponsored by Johnson & Johnson Consumer Inc. (J&JCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weigh 72 pounds or greater and have a body mass index (BMI)-for-age between the 5th and 95th percentile (inclusive) at Screening
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 10
Awards & highlights

Summary

This trial studies the safety of a med combo for teens with orthodontic pain over 10 days.

Who is the study for?
This trial is for adolescents aged 12-17 who weigh at least 72 pounds with a BMI in the normal range (5th to 95th percentile). They must have had an orthodontic procedure within the last 4 hours and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests a combined pain relief medication made of acetaminophen and naproxen sodium, taken multiple times over up to ten days by teens experiencing pain after orthodontic procedures.See study design
What are the potential side effects?
Possible side effects may include stomach pain, nausea, headache, dizziness, allergic reactions or liver issues due to acetaminophen; and stomach ulcers or bleeding, heartburn, kidney problems from naproxen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 72 pounds and my BMI is within the healthy range for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Treatment-related AEs

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acetaminophen/Naproxen Sodium Fixed CombinationExperimental Treatment1 Intervention
Participants will self-administer a fixed combination of acetaminophen/naproxen sodium orally as multiple doses over a period of up to 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen/Naproxen Sodium Fixed Combination
2023
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,503 Total Patients Enrolled
1 Trials studying Orthodontic Pain
24 Patients Enrolled for Orthodontic Pain
Todd BertochPrincipal InvestigatorJBR Clinical Research
1 Previous Clinical Trials
447 Total Patients Enrolled

Media Library

Acetaminophen/Naproxen Sodium Fixed Combination (Nonsteroidal Anti-inflammatory Drug (NSAID)) Clinical Trial Eligibility Overview. Trial Name: NCT05845008 — Phase 3
Orthodontic Pain Research Study Groups: Acetaminophen/Naproxen Sodium Fixed Combination
Orthodontic Pain Clinical Trial 2023: Acetaminophen/Naproxen Sodium Fixed Combination Highlights & Side Effects. Trial Name: NCT05845008 — Phase 3
Acetaminophen/Naproxen Sodium Fixed Combination (Nonsteroidal Anti-inflammatory Drug (NSAID)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05845008 — Phase 3
~0 spots leftby Jul 2025