A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

October 23, 2024 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kanwal, New South Wales, Australia, 2259
        • Paratus Clinical Kanwal ( Site 0004)
      • Randwick, New South Wales, Australia, 2031
        • Royal Hospital for Women ( Site 0008)
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice ( Site 0009)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital ( Site 0007)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Keogh Institute for Medical Research ( Site 0002)
  • Chile
      • Santiago, Chile, 7520440
        • Clinica Indisa [Santiago, Chile] ( Site 0101)
      • Santiago, Chile, 7591047
        • Clinica Las Condes ( Site 0109)
      • Santiago, Chile, 7650568
        • Clinica Alemana de Santiago ( Site 0107)
    • Region De Coquimbo
      • La Serena, Region De Coquimbo, Chile, 1710216
        • Hospital San Juan de Dios de La Serena ( Site 0110)
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8360160
        • Hospital San Borja Arriaran ( Site 0103)
  • New Zealand
      • Auckland, New Zealand, 0626
        • Southern Clinical Trials - Waitemata ( Site 0200)
      • Christchurch, New Zealand, 8013
        • Southern Clinical Trials Ltd ( Site 0201)
  • Poland
      • Bialystok, Poland, 15-224
        • Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
      • Katowice, Poland, 40-301
        • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
      • Katowice, Poland, 40-717
        • SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)
      • Katowice, Poland, 40-750
        • Clinical Medical Research Sp. z o.o. ( Site 0343)
      • Katowice, Poland, 40-851
        • Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
      • Rybnik, Poland, 44-200
        • LIFTMED ( Site 0325)
      • Skorzewo, Poland, 60-185
        • Examen Sp. z o.o. ( Site 0318)
      • Warszawa, Poland, 02-793
        • Clinical Best Solutions ( Site 0338)
      • Wroclaw, Poland, 50-547
        • Marek Elias Gabinety Ginekologiczne ( Site 0331)
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Cooperativa de Facultad Medica Sanacoop ( Site 0805)
      • Ponce, Puerto Rico, 00717-2348
        • Ponce Health Sciences University ( Site 0804)
      • San Juan, Puerto Rico, 00909
        • Gynecology & Endometriosis Center LLC ( Site 0806)
      • San Juan, Puerto Rico, 00917
        • Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
      • San Juan, Puerto Rico, 00918
        • Genes Fertility Institute Inc. ( Site 0803)
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Kazan State Medical University ( Site 0404)
      • Kazan, Russian Federation, 420033
        • Clinical Hospital #2 of Kazan city ( Site 0406)
      • Kazan, Russian Federation, 420097
        • LLC Scientific Research Medical Complex Your Health. ( Site 0405)
      • Moscow, Russian Federation, 101000
        • Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
      • Moscow, Russian Federation, 115280
        • State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
      • Saint Petersburg, Russian Federation, 199034
        • NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
      • Smolensk, Russian Federation, 214031
        • Uromed LLC ( Site 0410)
      • St. Petersburg, Russian Federation, 194354
        • Women clinic 22 ( Site 0400)
      • Tomsk, Russian Federation, 634050
        • Siberian State Medical University ( Site 0402)
  • Spain
      • Alicante, Spain, 03004
        • Instituto de Ciencias Medicas.ICM ( Site 0500)
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona ( Site 0501)
      • Madrid, Spain, 28050
        • Hospital Sanitas La Moraleja ( Site 0504)
    • Madrid
      • Aravaca, Madrid, Spain, 28023
        • Hospital Sanitas La Zarzuela ( Site 0502)
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76018
        • Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
      • Kyiv, Ukraine, 03040
        • Medical Center Verum ( Site 0900)
      • Kyiv, Ukraine, 03067
        • GI Institute of POG of NAMS of Ukraine ( Site 0905)
      • Kyiv, Ukraine, 04112
        • City Clinical Hospital No. 9 ( Site 0901)
      • Odessa, Ukraine, 65023
        • Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
      • Ternopil, Ukraine, 46400
        • Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
      • Zaporizhzhya, Ukraine, 69065
        • Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
      • Zaporizhzhya, Ukraine, 69071
        • Communal Institution Maternity Hospital 3 ( Site 0909)
      • Zaporizhzhya, Ukraine, 69071
        • Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35218
        • Cahaba Medical Care ( Site 0750)
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Synexus US Phoenix Southeast ( Site 0729)
      • Scottsdale, Arizona, United States, 85251
        • Synexus ( Site 0734)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks ( Site 0720)
    • California
      • Arcadia, California, United States, 91007
        • California Center for Clinical Research ( Site 0741)
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research ( Site 0716)
      • Simi Valley, California, United States, 93065
        • Alta California Medical Group ( Site 0721)
    • Connecticut
      • Groton, Connecticut, United States, 06340
        • Thameside OBGYN Center ( Site 0747)
      • Hamden, Connecticut, United States, 06518
        • WHUSA Fine and Gillette ( Site 0751)
    • Florida
      • Clearwater, Florida, United States, 33759
        • Florida Fertility Institute ( Site 0737)
      • Cutler Bay, Florida, United States, 33189
        • Advanced Pharma Research ( Site 0719)
      • Doral, Florida, United States, 33166
        • Doral Medical Research, LLC ( Site 0706)
      • Fort Lauderdale, Florida, United States, 33316
        • KO Clinical Research, LLC ( Site 0723)
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research, Corp. ( Site 0703)
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute ( Site 0709)
      • Miami, Florida, United States, 33465
        • New Horizon Research Center ( Site 0717)
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinic, LLC ( Site 0725)
      • South Miami, Florida, United States, 33143
        • QPS Miami Research Associates ( Site 0735)
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group Llc ( Site 0702)
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Southern Clinical Research Associates ( Site 0701)
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center ( Site 0742)
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Center ( Site 0715)
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research ( Site 0707)
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research ( Site 0743)
    • Texas
      • Austin, Texas, United States, 78705
        • Women Partners in Health ( Site 0745)
      • Corpus Christi, Texas, United States, 78412
        • Corpus Christi Clinic ( Site 0744)
      • Houston, Texas, United States, 77024
        • HD Research Corp ( Site 0738)
    • Virginia
      • Reston, Virginia, United States, 20190
        • PI-Coor Clinical Research, LLC ( Site 0710)
      • Richmond, Virginia, United States, 23225
        • Clinical Research Partners, LLC. ( Site 0704)
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's: Health, Research, Gynecology ( Site 0714)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis.
  • has cyclic AND non-cyclic, moderate to severe endometriosis-related pelvic pain (overall pelvic pain score ≥5 using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain).
  • has had spontaneous menstrual cycles before Visit 1.
  • has body mass index (BMI) between 18 kg/m^2 to 40 kg/m^2 at Visit 1.
  • is not pregnant, not breastfeeding, and agrees to follow the contraceptive guidance.
  • must agree to switch from her usual analgesic medication to only that which is permitted in the study.

Exclusion Criteria:

  • history of hysterectomy and/or bilateral oophorectomy.
  • has undiagnosed vaginal bleeding.
  • has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic.
  • has a clinically significant gynecologic condition identified in the screening evaluation.
  • has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs.
  • has a known allergy/sensitivity or contraindication to gefapixant or its excipients.
  • has an allergy/sensitivity/intolerance to naproxen sodium (rescue medication) or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • has a history of endometriosis-related pain that was non-responsive to treatment with combined hormonal contraceptives (CHCs), gonadotropin-releasing hormone (GnRH) antagonists, GnRH agonists, progestins, or aromatase inhibitors.
  • has a positive urine pregnancy test at any time before randomization.
  • has required more than 2 weeks of continuous use of narcotics for treatment of endometriosis-related pain within 6 months of Visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gefapixant
Participants will receive a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets will also be provided to participants for use as rescue medication for endometriosis-related pain.
Drug: Gefapixant
Gefapixant tablet 45 mg taken orally
Other Names:
  • MK-7264
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
Placebo Comparator: Placebo
Participants will receive a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets will also be provided to participants for use as rescue medication for endometriosis-related pain.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
Time Frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Pelvic pain (cyclic pain associated with menses, and non-cyclic pain not associated with menses) severity score was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The averages of the daily pelvic pain scores (cyclic and non-cyclic, combined) entered in participants' electronic diaries (eDiaries) were calculated for Baseline and Treatment Cycle 2 (approximately Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline.
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Percentage of Participants Who Experienced an Adverse Event
Time Frame: Up to approximately 10 weeks
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, this analysis included AEs reported up to 14 days after end of study intervention.
Up to approximately 10 weeks
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to approximately 8 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
Time Frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Cyclic pelvic pain (associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the daily cyclic pelvic pain scores entered in participants' eDiaries was calculated for Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline.
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
Time Frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Non-cyclic pelvic pain (not associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the non-cyclic daily pelvic pain scores entered in participants' eDiaries was calculated for the Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates decrease in pain severity from baseline.
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7264-034
  • 2018-001098-26 (EudraCT Number)
  • MK-7264-034 (Other Identifier: MSD Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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