CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 221 enrolled
Drug / intervention
Naproxen Sodium (Aleve, BAY117031) +2 moredrug
Likely dose
Naproxen Sodium (Aleve, BAY117031) 220 mgfrom 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.

Search/NCT04307940
NCT04307940Phase 4Completed
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A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain

Bayer·interventional·Posted Mar 13, 2020·Updated Jul 14, 2022

In Brief

A Phase 4 clinical trial evaluating Naproxen Sodium (Aleve, BAY117031), Hydrocodone/Acetaminophen, and 1 other intervention for Pain. Completed, enrolled 221 participants across 1 site.

Detailed Summary

With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary relief of minor aches and pains. Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 13, 2020
Enrollment StartMar 12, 2020
Primary CompletionOct 2, 2020
Study CompletionOct 5, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.3 years ago

Interventions

Naproxen Sodium (Aleve, BAY117031)drug

220 mg per tablet, two tablets (440 mg), intake a single dose orally.

Hydrocodone/Acetaminophendrug

5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.

Placebodrug

two tablets, intake a single dose orally.