CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 202 enrolled
Drug / intervention
Diclofenac Test (lower dose) +3 moredrug
Likely dose
Celecoxib 400 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.

Search/NCT00985439
NCT00985439Phase 2Completed

A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Iroko Pharmaceuticals, LLC·interventional·Posted Sep 28, 2009·Updated May 22, 2012

In Brief

A Phase 2 clinical trial evaluating Diclofenac Test (lower dose), Diclofenac Test (upper dose), and 2 other interventions for Dental Pain. Completed, enrolled 202 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.8 years ago

Interventions

Diclofenac Test (lower dose)drug

18-mg Single dose

Diclofenac Test (upper dose)drug

35-mg Single dose

Celecoxib 400 mgdrug

Capsules 2 x 200 mg Single-dose

Placebodrug

Capsules 2 Single-dose