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Nonsteroidal Anti-inflammatory Drug (NSAID)

Combo Pain Reliever for Toothache

Phase 3

Recruiting

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

Have a negative urine drug screen at screening, and on day of surgical procedure

Surgical removal of three or four third molars, of which, two must be mandibular impactions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 24 hours

Awards & highlights

Study Summary

This trial tests if a combo of drugs works better than single drugs or placebo to reduce post-dental surgery pain.

Who is the study for?

This trial is for individuals over 100 pounds with a BMI of 17.5-30.4, who've had certain dental surgeries and can handle post-surgical pain without heavy drug use or alcohol. Women must not be pregnant and agree to contraception; men too if their partner is at risk of pregnancy.Check my eligibility

What is being tested?

The study tests how well a combined acetaminophen/naproxen sodium pill manages dental surgery pain compared to each drug alone or a placebo. Participants will receive one of these treatments randomly.See study design

What are the potential side effects?

Possible side effects include digestive issues like stomach pain, heartburn, nausea; allergic reactions; headache; dizziness; sleepiness; and liver problems from acetaminophen or kidney issues from naproxen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My drug tests before and on the day of surgery were negative.

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I had surgery to remove 3 or 4 wisdom teeth, including 2 in my lower jaw.

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I agree to follow the study's birth control requirements.

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I weigh at least 100 pounds and my BMI is between 17.5 and 30.4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)

Secondary outcome measures

Percentage of Participants who Request Rescue Analgesic During the First 12 hours

Time to First Request of Rescue Analgesic

Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Acetaminophen/Naproxen Sodium Fixed CombinationExperimental Treatment1 Intervention

Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.

Group II: Naproxen SodiumActive Control2 Interventions

Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.

Group III: AcetaminophenActive Control1 Intervention

Participants will receive a single oral dose of two Acetaminophen tablets.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive a single oral dose of two Placebo capsules.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor

52 Previous Clinical Trials

5,054 Total Patients Enrolled

1 Trials studying Pain

120 Patients Enrolled for Pain

Todd BertochPrincipal InvestigatorJBR Clinical Research

1 Previous Clinical Trials

Media Library

Acetaminophen/Naproxen Sodium Fixed Combination (Nonsteroidal Anti-inflammatory Drug (NSAID)) Clinical Trial Eligibility Overview. Trial Name: NCT05761574 — Phase 3

Pain Research Study Groups: Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium, Acetaminophen, Placebo

Pain Clinical Trial 2023: Acetaminophen/Naproxen Sodium Fixed Combination Highlights & Side Effects. Trial Name: NCT05761574 — Phase 3

Acetaminophen/Naproxen Sodium Fixed Combination (Nonsteroidal Anti-inflammatory Drug (NSAID)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05761574 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted into the research study?

"This medical research is open to participants who are between the ages of 16 and 50."

Answered by AI

Do I qualify for enrollment in this research?

"This clinical trial seeks 440 participants with pain between the ages of 16 and 50. To be eligible, individuals must meet these criteria."

Answered by AI

Has the Acetaminophen/Naproxen Sodium Fixed Combination been cleared by regulatory authorities?

"Our team at Power evaluated the safety of Acetaminophen/Naproxen Sodium Fixed Combination to be a 3 due to existing evidence supporting its efficacy and repeated studies that attest to its safe usage."

Answered by AI

Is recruitment for the trial ongoing?

"According to the clinicaltrials.gov database, this specific medical trial is not currently open for recruitment. Despite being initially posted on May 31st 2023 and most recently edited on February 27th 2023, it does not appear that enrollment has commenced yet. On the other hand, 373 alternative studies are actively searching for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

2023. "A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761574.