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Acetaminophen + Naproxen for Postoperative Pain
Study Summary
This trial tests if taking a combination of acetaminophen/naproxen sodium can reduce pain over 2 days.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Acetaminophen/Naproxen Sodium Fixed Combination
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How can I participate in this research trial?
"To be eligible for the trial, applicants should experience pain and have attained between 16 to 65 years of age. Presently, a total of 120 patients are being sought after."
Has the Acetaminophen/Naproxen Sodium Fixed Combination been legitimized by the FDA?
"Extensive clinical data has been gathered in support of Acetaminophen/Naproxen Sodium Fixed Combination's safety, and as such it warrants a rating of 3."
In what locales is this clinical investigation being performed?
"At the moment, 4 medical facilities are recruiting for this trial: First Surgical Hospital in Bellaire, The Heights Hospital in Houston, and Endeavor Clinical Trails in San Antonio being among them."
Does this trial take individuals aged forty or older as participants?
"This clinical trial only considers participants aged 16 to 65; those younger than sixteen or older than sixty-five should look into the 134 and 663 studies targeting their respective age groups."
Are there still available vacancies for this research endeavor?
"According to clinicaltrials.gov, this particular medical trial is not presently taking on new patients; the study was initially uploaded on September 1st 2023 and last updated May 11th of the same year. Despite this, there are 878 other trials actively seeking participants."
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