CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 280 enrolled
Drug / intervention
Ibuprofen 300 mg Oral Tablet +3 moredrug
Likely dose
Ibuprofen 300 mg Oral Tabletfrom 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/NCT03785756
NCT03785756Phase 3Completed
CompareCT.gov

A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multiple-Dose, Active and Placebo-Controlled Efficacy Study of Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Reckitt Benckiser Healthcare (UK) Limited·interventional·Posted Dec 24, 2018·Updated Jun 3, 2024

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 300 mg Oral Tablet, Ibuprofen 200 mg Oral Tablet, and 2 other interventions for Pain. Completed, enrolled 280 participants across 1 site.

Detailed Summary

This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartApr 29, 2019
Primary CompletionFeb 20, 2020
Study CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.5 years ago

Interventions

Ibuprofen 300 mg Oral Tabletdrug

2 × 300 mg tablets at Hours 0 and 12

Ibuprofen 200 mg Oral Tabletdrug

2 × 200 mg tablets at Hours 0, 8, and 16

Placebo of PR tabletdrug

2 tablets up to four times in 24 hours

Placebo of IR tabletdrug

2 tablets up to four times in 24 hours