CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 294 enrolled
Drug / intervention
Ibuprofen 200Mg Oral Cap +3 moredrug
Likely dose
Ibuprofen 200Mg Oral Capfrom 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/NCT05484401
NCT05484401Phase 3Completed

A Randomised, Double-blind, Double-dummy, Parallel-group, Single Dose, Active and Placebo-controlled Efficacy and Pharmacokinetics/Pharmacodynamics Study of 2 x 200 mg Ibuprofen Liquid Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars.

Reckitt Benckiser Healthcare (UK) Limited·interventional·Posted Aug 2, 2022·Updated Jun 22, 2023

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 200Mg Oral Cap, Ibuprofen 200Mg Oral Tablet, and 2 other interventions for Tooth, Impacted and 2 related conditions. Completed, enrolled 294 participants across 1 site.

Detailed Summary

This is a single centre, three-arm randomised, double-blind, double-dummy, parallel group, single-dose, active and placebo-controlled efficacy and pharmacokinetics/ pharmacodynamics study to evaluate the efficacy and safety of 2 x 200 mg Ibuprofen Liquid Capsules in subjects with post-operative dental pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedAug 2, 2022
Enrollment StartAug 9, 2022
Primary CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.9 years ago

Interventions

Ibuprofen 200Mg Oral Capdrug

2 x 200mg Liquid Capsules once in 12 hours

Ibuprofen 200Mg Oral Tabletdrug

2 x 200mg Tablets once in 12 hours

Placebo Liquid Capsuleother

2 x Liquid Capsules once in 12 hours

Placebo Tabletsother

2 x Tablets once in 12 hours