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Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed

NCT04307940 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2022-07-14

Study results available
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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).

Conditions

Interventions

DRUG

Naproxen Sodium (Aleve, BAY117031)

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

DRUG

Hydrocodone/Acetaminophen

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

DRUG

Placebo

two tablets, intake a single dose orally.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2020-10-02
Completion
2020-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307940 on ClinicalTrials.gov