A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative P… (NCT05868122) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
United States143 participantsStarted 2023-09-07
Plain-language summary
The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Scheduled to undergo primary, unilateral, distal, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. Participants who have previously undergone bunionectomy on the contralateral foot will not be prohibited from enrolling in this study if performed greater than or equal to (\>=) 6 months
* Are able to comprehend and follow the requirements of the study (including pre-surgical instructions provided by the site and availability on scheduled visit dates) based upon research site personnel's assessment
* Provide written informed consent (for participants who are below the age of legal consent, parent or legally authorized representative provides written informed consent and the participant provides written assent)
* Participant agrees to the contraceptive requirements
* Are willing for this to be the only investigational product used during the study
* Have a negative urine drug screen at screening, and on day of surgical procedure. a) a positive drug screen for a known prescribed concomitant medication that is not otherwise exclusionary will not disqualify a participant; b) drug and alcohol screen results must be negative for a participant to receive study medication, a positive Tetrahydrocannabinol (THC) screen w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-weighted Sum of Pain Intensity Difference Score from 0 to 24 Hours After Dosing (SPID 0-24)