At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 447 enrolled
Drug / intervention
Acetaminophen/Naproxen Sodium Fixed Combination +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain
In Brief
A Phase 3 clinical trial evaluating Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium, and 2 other interventions for Pain. Completed, enrolled 447 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedMar 2023
Enrollment StartMay 2023
Primary CompletionMay 2024
Study CompletionMay 2024
TodayJul 2026
First PostedMar 9, 2023
Enrollment StartMay 22, 2023
Primary CompletionMay 17, 2024
Study CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 3.3 years ago
Interventions
Acetaminophen/Naproxen Sodium Fixed Combinationdrug
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen Sodiumdrug
Naproxen Sodium will be administered orally.
Acetaminophendrug
Acetaminophen will be administered orally.
Placebodrug
Placebo will be administered orally.