Trial Condition(s):

Dental Care, Pain

Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery

Bayer Identifier:

Trial_CC-01566

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This was a single-dose, randomized, parallel, double-blind, singlecenter,
placebo and active treatment-controlled study designed for
225 subjects. Subjects were randomly assigned at a ratio of 2:2:1 to
receive two capsules of either naproxen sodium, acetaminophen, or
placebo. Subjects rated their pain intensity on categorical (CAT) and
visual analog scales (VAS). Pain relief was rated on categorical scales.
Pain intensity was evaluated immediately prior to study drug
administration. Pain intensity, pain relief, and "pain half gone" were
evaluated at 20, 30, 40, and 60 minutes and hourly thereafter for 12
hours following study drug administration.

Inclusion Criteria
:
 -  Healthy males and females atleast 15 years of age with at least
moderate post operative pain associated with surgical removal of
three or four third molars (including at least one mandibular partial or
complete bony impaction) were enrolled in the study.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
223
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteers
N/A

Where to Participate

Locations
Status
LocationsStatus

Trial Design