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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
Study 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 belowSelect...
I weigh at least 72 pounds and my BMI is within the healthy range for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 10
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.
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Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,494 Total Patients Enrolled
1 Trials studying Orthodontic Pain
24 Patients Enrolled for Orthodontic Pain
Todd BertochPrincipal InvestigatorJBR Clinical Research
1 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the study's birth control requirements.I weigh at least 72 pounds and my BMI is within the healthy range for my age.I have not had any dental braces or similar procedures within 4 hours before my first visit.
Research Study Groups:
This trial has the following groups:- Group 1: Acetaminophen/Naproxen Sodium Fixed Combination
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experimental protocol accept applicants aged 25 and above?
"The current recruitment phase is seeking participants between 12 and 16 years old."
Answered by AI
Has the Acetaminophen/Naproxen Sodium Fixed Combination been verified by the FDA?
"Acetaminophen/Naproxen Sodium Fixed Combination is rated a 3 for safety as this trial has reached the third phase, indicating there is evidence attesting to its efficacy and supporting data that it is safe."
Answered by AI
Is my participation in this clinical research permissible?
"To qualify for inclusion in the study, potential participants must exhibit orthodontic discomfort and be between 12-16 years of age. A total of 75 patients will be recruited for this trial."
Answered by AI
Are there any openings available in this clinical trial?
"According to the information on clinicaltrials.gov this study is not presently in need of patients, having been initially posted on September 19th 2023 and last updated April 25th 2023. Nevertheless, there are two other studies that require volunteers at present."
Answered by AI
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