At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 328 enrolled
Drug / intervention
Diclofenac potassium +3 moredrug
Likely dose
Diclofenac potassium 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Diclofenac potassium, Ibuprofen, and 2 other interventions for Post Operative Dental Pain. Completed, enrolled 328 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Operative Dental Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedJun 2015
Primary CompletionAug 2015
TodayJul 2026
First PostedJun 19, 2015
Enrollment StartApr 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.0 years ago
Interventions
Diclofenac potassiumdrug
Single dose of diclofenac 50 mg soft gelatin capsule
Ibuprofendrug
Single dose of ibuprofen 400 mg tablet
Placebo to ibuprofendrug
Single dose of placebo to ibuprofen 400 mg tablet
Placebo to diclofenac potassiumdrug
Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule