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A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

NCT03404206 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2019-07-18

Study results available
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Summary

To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.

To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Naproxen Sodium (Aleve, BAY117031)

220 mg x 2 tablets, oral, single dose

DRUG

Ibuprofen (Advil)

200 mg x 2 tablets, oral, single dose

DRUG

Placebo

Matching placebo, 2 tablets, oral, single dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-07-06
Completion
2018-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03404206 on ClinicalTrials.gov