CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
Etoricoxib +4 moredrug
Likely dose
Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 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.

Search/NCT01462370
NCT01462370Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea

Organon and Co·interventional·Posted Oct 31, 2011·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating Etoricoxib, Ibuprofen, and 3 other interventions for Dysmenorrhea. Completed, enrolled 139 participants.

Detailed Summary

This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2011
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.7 years ago

Interventions

Etoricoxibdrug

Etoricoxib 120 mg tablet given orally for one dose.

Ibuprofendrug

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

Placebo to etoricoxibdrug

Placebo to etoricoxib, one tablet.

Placebo to ibuprofendrug

Placebo to ibuprofen, up to four 3-capsule doses.

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mgdrug

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.