Trial Condition(s):

Dental Care, Pain

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

Bayer Identifier:

Trial_CC-01550

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This single center, single-dose randomized, double-blind, parallel,
placebo- and active- controlled study was designed for 175 evaluable
subjects. Subjects were randomly assigned to one of the 3 treatment
groups in the ratio of 2:2:1 (naproxen 187.5 mg [NAP187.5] or
ibuprofen 200 mg [IBU200] or placebo). Pain response was evaluated
immediately prior to administration of study drug, 1 hour and hourly
thereafter up to 12 hours. Pain intensity and pain relief were
measured on categorical scales and subjects were asked if their pain
was at least half gone from baseline at each time point. Subjects
remained in the study for up to 12 hours. Back up analgesic
medications was available for those subjects who experienced
insufficient pain relief from the study medication.

Inclusion Criteria
:
 -  Healthy subjects > 15 years of age who experienced at least moderate
pain following the surgical extraction of one or two third molars (at
least one must be a mandibular partial bony or complete bony
impaction).
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
175
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteers
N/A

Where to Participate

Locations
Status
LocationsStatus

Trial Design