CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 187 enrolled
Drug / intervention
Gefapixant +2 moredrug
Likely dose
Gefapixant 45 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/NCT03654326
NCT03654326Phase 2Completed
CompareCT.gov

A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain

Merck Sharp & Dohme LLC·interventional·Posted Aug 31, 2018·Updated Nov 4, 2024

In Brief

A Phase 2 clinical trial evaluating Gefapixant, Placebo, and 1 other intervention for Endometriosis-related Pain. Completed, enrolled 187 participants across 78 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily pelvic pain score (cyclic and non-cyclic, combined) during Treatment Cycle 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis-related Pain
CountriesAustralia, Chile, New Zealand, Poland, Puerto Rico, Russia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartSep 11, 2018
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago

Interventions

Gefapixantdrug

Gefapixant tablet 45 mg taken orally

Placebodrug

Placebo matching gefapixant tablet taken orally

Naproxendrug

Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator