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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

NCT02476422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2016-10-17

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02476422 on ClinicalTrials.gov