Trials / Completed
CompletedNCT03654326
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gefapixant | Gefapixant tablet 45 mg taken orally |
| DRUG | Placebo | Placebo matching gefapixant tablet taken orally |
| DRUG | Naproxen | Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator |
Timeline
- Start date
- 2018-09-11
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2018-08-31
- Last updated
- 2024-11-04
- Results posted
- 2021-07-07
Locations
78 sites across 9 countries: United States, Australia, Chile, New Zealand, Poland, Puerto Rico, Russia, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03654326. Inclusion in this directory is not an endorsement.