NCT02476422

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post Operative Dental Pain

Interventions

Type	Name	Description
DRUG	Diclofenac potassium	Single dose of diclofenac 50 mg soft gelatin capsule
DRUG	Ibuprofen	Single dose of ibuprofen 400 mg tablet
DRUG	Placebo to ibuprofen	Single dose of placebo to ibuprofen 400 mg tablet
DRUG	Placebo to diclofenac potassium	Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-06-19
• Last updated: 2016-10-17
• Results posted: 2016-10-17

Locations

1 site across 1 country: United States