A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:April 2015
End Date:August 2015

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Tolerability of 50 mg Diclofenac Potassium Soft Gelatin Capsules Compared With 400 mg Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

The study is designed to assess the efficacy and tolerability of diclofenac potassium soft
gelatin capsules compared with ibuprofen tablets in patients with moderate to severe
postoperative dental pain.


Inclusion Criteria:

- Patients requiring surgical removal of 2 ipsilateral third molars, of which the
mandibular must be fully or partially impacted. The ipsilateral maxillary third molar
may be of any impaction level.

- Patients having a moderate to severe Baseline pain intensity as assessed by a score
of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS,
confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after
local anesthetic dissipation.

Exclusion Criteria:

- Patients who require the removal of a single third molar, or 2 ipsilateral third
molars where mandibular molar is not fully or partially impacted.

- Patients with active peptic ulcer disease or a history of significant
gastrointestinal disease or any gastrointestinal bleeding.

- Patients with coagulation or bleeding disorders.

- Patients with a positive drug or alcohol screen.

- Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic,
muscle relaxant, or tranquilizer within 5 elimination half-lives before
administration of study drug (other than surgical anesthetic prior to and during
dental surgery).

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
1
site
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials