CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 256 enrolled
Drug / intervention
Ibuprofen 600 mg Extended-Release Tablets +1 moredrug
Likely dose
Ibuprofen 600 mg Extended-Release Tabletsfrom 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/NCT00707057
NCT00707057Phase 3Completed
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Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study

SCOLR Pharma, Inc.·interventional·Posted Jun 30, 2008·Updated Mar 24, 2011

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 600 mg Extended-Release Tablets and Placebo for Pain and 2 related conditions. Completed, enrolled 256 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Post-Operative Pain, Third Molar Extraction
CountriesUnited States
CollaboratorsAAIPharma, Jean Brown Research

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.0 years ago

Interventions

Ibuprofen 600 mg Extended-Release Tabletsdrug

Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Placebodrug

Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.