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

Novartis

Status and phase: Completed; Phase 3

Conditions: Post Operative Dental Pain

Treatments: Drug: Diclofenac potassium; Drug: Placebo to diclofenac potassium; Drug: Ibuprofen; Drug: Placebo to ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02476422

CCAT458M2402

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Dilcofenac potassium + placebo to Ibuprofen

Experimental group

Description:

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.

Treatment:

Drug: Placebo to ibuprofen

Drug: Diclofenac potassium

Ibuprofen + placebo to diclofenac potassium

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Drug: Placebo to diclofenac potassium