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 range16 Years – 65 Years
SexALL
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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…
What they're measuring
1
Time-weighted Sum of Pain Intensity Difference Score from 0 to 24 Hours After Dosing (SPID 0-24)