Trial Condition(s):

Dental Care, Pain

Ibuprofen, and placebo in the treatment of pain secondary to dental impaction surgery

Bayer Identifier:

Trial_CC-00594

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

This was a single-dose, randomized, parallel, double-blind design
requiring 175 evaluable subjects at a single center. Subjects were
randomly assigned to one of the 3 groups in 2:2:1 ratio to receive a
single dose of naproxen (187.5 mg), ibuprofen (200 mg), or placebo.
After dosing with study medication, the subjects had to remain at the
study site for 2 hours. Analgesic response was evaluated on
categorical scales by subjects’ ratings of their pain intensity and pain
relief. Pain intensity was evaluated immediately prior to study drug
administration, and both pain intensity and pain relief were evaluated
hourly thereafter for 12 hours following study drug administration.

Inclusion Criteria
:
 -  Generally healthy subjects, at least 15 years of age, with at least
moderate pain following surgical extraction of one or 2 third molars
with at least one being a mandibular partial or complete bony
impaction were enrolled in the study.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
12
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