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Nonsteroidal Anti-inflammatory Drug (NSAID)
Acetaminophen + Naproxen for Orthodontic Pain
Phase 1
Waitlist Available
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
Has undergone an orthodontic procedure within 72 hours prior to dosing
Are willing for investigational product of this study to be the only analgesic product used during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose up to 48 hours post dose
Awards & highlights
Study Summary
This trial looks at how age & weight affect the way adolescents metabolize pain medication for orthodontic pain.
Who is the study for?
Adolescents aged 12 to <17 with orthodontic pain, weighing at least 72 pounds and within the healthy BMI range for their age. They must not have eaten for 10 hours before taking the study drug, be non-tobacco users for at least a year, and agree to use only the study analgesic. Females must test negative for pregnancy and all participants should be generally healthy without significant medical issues.Check my eligibility
What is being tested?
The trial is testing a new combination tablet of acetaminophen/naproxen sodium in adolescents who've recently had orthodontic procedures. It aims to understand how different factors like age and weight affect how these drugs work in young people's bodies.See study design
What are the potential side effects?
Possible side effects may include digestive issues such as stomach pain or heartburn, allergic reactions if sensitive to NSAIDs or ingredients in the tablets, increased risk of bleeding disorders, liver or kidney problems due to acetaminophen or naproxen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose up to 48 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 48 hours post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Central Volume of Distribution (Vc/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium
Apparent Inter-compartmental Clearance (Q/F) of Acetaminophen/Naproxen Sodium
+8 moreSecondary outcome measures
Number of Participants with Adverse Events (AEs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Acetaminophen /Naproxen SodiumExperimental Treatment1 Intervention
Participants with age group 12 to less than (<) 17 years who undergone a non-surgical orthodontic procedure will enroll and receive fixed dose combination of acetaminophen/naproxen sodium tablet orally on baseline (Day 0).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen/Naproxen Sodium
2023
Completed Phase 1
~30
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,470 Total Patients Enrolled
1 Trials studying Orthodontic Pain
Johnson & Johnson Consumer Inc. (J&JCI) Clinical TrialStudy DirectorJohnson & Johnson Consumer Inc. (J&JCI)
2 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not consume anything that contains xanthines like tea, coffee, cola drinks, energy drinks, or chocolate 48 hours before and during the study.You have taken any vitamins, dietary supplements, or herbal remedies in the week leading up to starting the study drug.You have taken ibuprofen within 6 hours before receiving the study medication.You are allergic to acetaminophen, naproxen, or other types of pain relievers like aspirin.You have had issues with substance abuse in the past year, as determined by the study leader.You have eaten grapefruit or savoy oranges in the 2 days leading up to the study and during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Acetaminophen /Naproxen Sodium
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is the upper age limit of this trial restricted to participants no older than 20?
"The age requirements for this clinical trial are between 12 and 16."
Answered by AI
Can individuals safely consume Acetaminophen/Naproxen Sodium without consequence?
"Since this is a Phase 1 trial, meaning that there is only minimal data supporting its efficacy and safety, Acetaminophen/Naproxen Sodium was assigned the score of one."
Answered by AI
Are there any available slots in this medical experiment for potential participants?
"Per the information on clinicaltrials.gov, this research trial is not presently taking enrolment. First posted in August of 2023 and last modified nearly six months later, no new participants are being sought out at present; however there are other studies that are welcoming candidates currently."
Answered by AI
Is it possible for me to sign up for this research endeavor?
"Prospective participants must have an orthodontic-related pain, and be aged between 12 to 16 years old. With a total of 30 enrollees for the trial, selection is competitive."
Answered by AI
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