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

Endometriosis-related Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654326
• Other study ID #: 7264-034
• Secondary ID: 2018-001098-26MK
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis-related Pain

Intervention

Drug:
• Gefapixant
Gefapixant tablet 45 mg taken orally
• Placebo
Placebo matching gefapixant tablet taken orally
• Naproxen
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Australia,  Chile,  New Zealand,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2	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)
Primary	Percentage of Participants Who Experienced an Adverse Event	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
Primary	Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event	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	Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2	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)
Secondary	Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2	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)