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Nonsteroidal Anti-inflammatory Drug (NSAID)
Acetaminophen + Naproxen for Postoperative Pain
Phase 3
Recruiting
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
Females have a negative urine pregnancy at screening and on the morning of surgery
Weight of 100 pounds or greater and have a body mass index (BMI) of 17.5 to 38.0 (inclusive) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours
Awards & highlights
Study Summary
This trial tests if taking a combination of acetaminophen/naproxen sodium can reduce pain over 2 days.
Who is the study for?
This trial is for individuals scheduled for bunion surgery, weighing at least 100 pounds with a BMI of 17.5-38.0, who can follow study procedures and are not on certain medications or have specific health conditions that could affect their safety or the study's integrity. Participants must agree to use contraception and avoid other investigational drugs.Check my eligibility
What is being tested?
The trial tests a fixed combination of acetaminophen/naproxen sodium against a placebo to see if it reduces pain after bunion surgery over 48 hours. Patients will receive multiple doses and their pain levels will be compared to those taking the placebo.See study design
What are the potential side effects?
Potential side effects may include digestive issues like stomach pain or ulcers due to naproxen, liver problems from acetaminophen, allergic reactions, dizziness, headaches, or increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, as confirmed by tests.
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I weigh at least 100 pounds and my BMI is between 17.5 and 38.
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I agree to only use the study's treatment during the trial.
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My surgery lasted less than 2 hours from start to finish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 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 Score from 0 to 24 Hours After Dosing (SPID 0-24)
Secondary outcome measures
Percentage of Participants who use Rescue Medication During the First 12 Hours
Time to Confirmed Perceptible Pain Relief (TCPR)
Time to First use of Rescue Medication
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Acetaminophen/Naproxen Sodium Fixed CombinationExperimental Treatment1 Intervention
Participants will receive oral doses of two Acetaminophen/Naproxen Sodium Fixed Combination tablets taken with water. Multiple doses will be administered over a 48-hour period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive oral doses of two placebo tablets taken with water. Multiple doses will be administered over a 48-hour period.
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Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,374 Total Patients Enrolled
1 Trials studying Pain
440 Patients Enrolled for Pain
Johnson & Johnson Consumer Inc. (J&JCI) Clinical TrialStudy DirectorJohnson & Johnson Consumer Inc. (J&JCI)
2 Previous Clinical Trials
77 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for HIV, hepatitis B, or hepatitis C.I weigh at least 100 pounds and my BMI is between 17.5 and 38.My drug tests are negative, except for prescribed meds or THC not on surgery day.My surgery lasted less than 2 hours from start to finish.I have had a stomach ulcer or bleeding disorder diagnosed by a camera test in the last 2 years.You will be excluded from the study if you have been using certain pain medications, opioids, tranquilizers, heavy drinking, or substances such as tobacco, or if you have taken specific medications within a certain timeframe before the surgery.I understand and can follow the study's requirements.I agree to only use the study's treatment during the trial.I am pregnant, breastfeeding, or trying to get pregnant.I am not pregnant, as confirmed by tests.I can follow instructions and assess my pain as required.I am allergic to certain pain relievers like naproxen, oxycodone, or acetaminophen.I am scheduled for a specific foot surgery and haven't had the same surgery on the other foot in the last 6 months.I experienced moderate or severe pain and scored 5 or more on a pain scale after my procedure.My partner is pregnant or trying to become pregnant.I cannot swallow large pills.
Research Study Groups:
This trial has the following groups:- Group 1: Acetaminophen/Naproxen Sodium Fixed Combination
- Group 2: 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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