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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 belowSelect...
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
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My drug tests before and on the day of surgery were negative.I had surgery to remove 3 or 4 wisdom teeth, including 2 in my lower jaw.My pain after surgery fits the trial's criteria.I haven't taken immunosuppressive drugs in the last 2 weeks.I agree to follow the study's birth control requirements.I am pregnant, breastfeeding, trying to conceive, or my partner is pregnant or trying to conceive.I am allergic to NSAIDs like aspirin or naproxen, acetaminophen, or opioids.I weigh at least 100 pounds and my BMI is between 17.5 and 30.4.You take painkillers 5 or more times a week.I cannot swallow large pills or capsules.I have had a stomach ulcer or bleeding disorder diagnosed by a camera test in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Acetaminophen/Naproxen Sodium Fixed Combination
- Group 2: Naproxen Sodium
- Group 3: Acetaminophen
- Group 4: Placebo
Awards:
This trial has 1 awards, including:- 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.
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