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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Operative Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dilcofenac potassium + placebo to Ibuprofen

Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.

Group Type EXPERIMENTAL

Diclofenac potassium

Intervention Type DRUG

Single dose of diclofenac 50 mg soft gelatin capsule

Placebo to ibuprofen

Intervention Type DRUG

Single dose of placebo to ibuprofen 400 mg tablet

Ibuprofen + placebo to diclofenac potassium

Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Single dose of ibuprofen 400 mg tablet

Placebo to diclofenac potassium

Intervention Type DRUG

Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Interventions

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Diclofenac potassium

Single dose of diclofenac 50 mg soft gelatin capsule

Intervention Type DRUG

Ibuprofen

Single dose of ibuprofen 400 mg tablet

Intervention Type DRUG

Placebo to ibuprofen

Single dose of placebo to ibuprofen 400 mg tablet

Intervention Type DRUG

Placebo to diclofenac potassium

Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Intervention Type DRUG

Other Intervention Names

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diclofenac-K Ibuprofen acid Placebo Placebo

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No