A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
- Conditions
- Endometriosis-related Pain
- Interventions
- Registration Number
- NCT03654326
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 187
- 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 β₯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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Gefapixant Placebo 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. Gefapixant 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. Gefapixant Naproxen 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. Placebo Naproxen 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 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.
Percentage of Participants Who Experienced an Adverse Event 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.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2 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.
Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2 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.
Trial Locations
- Locations (78)
Synexus US Phoenix Southeast ( Site 0729)
πΊπΈChandler, Arizona, United States
Lynn Institute of the Ozarks ( Site 0720)
πΊπΈLittle Rock, Arkansas, United States
Thameside OBGYN Center ( Site 0747)
πΊπΈGroton, Connecticut, United States
WHUSA Fine and Gillette ( Site 0751)
πΊπΈHamden, Connecticut, United States
Lenus Research & Medical Group Llc ( Site 0702)
πΊπΈSweetwater, Florida, United States
Southern Clinical Research Associates ( Site 0701)
πΊπΈMetairie, Louisiana, United States
Palmetto Clinical Research ( Site 0707)
πΊπΈSummerville, South Carolina, United States
Hospital San Borja Arriaran ( Site 0103)
π¨π±Santiago, Region Metropolitana, Chile
Clinica Las Condes ( Site 0109)
π¨π±Santiago, Chile
Clinica Alemana de Santiago ( Site 0107)
π¨π±Santiago, Chile
Southern Clinical Trials Ltd ( Site 0201)
π³πΏChristchurch, New Zealand
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
π΅π±Katowice, Poland
Clinical Medical Research Sp. z o.o. ( Site 0343)
π΅π±Katowice, Poland
Marek Elias Gabinety Ginekologiczne ( Site 0331)
π΅π±Wroclaw, Poland
Cooperativa de Facultad Medica Sanacoop ( Site 0805)
π΅π·Bayamon, Puerto Rico
Ponce Health Sciences University ( Site 0804)
π΅π·Ponce, Puerto Rico
Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
π΅π·San Juan, Puerto Rico
Women clinic 22 ( Site 0400)
π·πΊSt. Petersburg, Russian Federation
Kazan State Medical University ( Site 0404)
π·πΊKazan, Russian Federation
LLC Scientific Research Medical Complex Your Health. ( Site 0405)
π·πΊKazan, Russian Federation
Clinical Hospital #2 of Kazan city ( Site 0406)
π·πΊKazan, Russian Federation
Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
π·πΊMoscow, Russian Federation
State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
π·πΊMoscow, Russian Federation
NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
π·πΊSaint Petersburg, Russian Federation
Siberian State Medical University ( Site 0402)
π·πΊTomsk, Russian Federation
Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
πΊπ¦Ivano-Frankivsk, Ukraine
City Clinical Hospital No. 9 ( Site 0901)
πΊπ¦Kyiv, Ukraine
Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
πΊπ¦Odessa, Ukraine
Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
πΊπ¦Ternopil, Ukraine
Florida Fertility Institute ( Site 0737)
πΊπΈClearwater, Florida, United States
KO Clinical Research, LLC ( Site 0723)
πΊπΈFort Lauderdale, Florida, United States
Inpatient Research Clinic, LLC ( Site 0725)
πΊπΈMiami Lakes, Florida, United States
Doral Medical Research, LLC ( Site 0706)
πΊπΈDoral, Florida, United States
Tufts Medical Center ( Site 0742)
πΊπΈBoston, Massachusetts, United States
Chattanooga Medical Research ( Site 0743)
πΊπΈChattanooga, Tennessee, United States
Seattle Women's: Health, Research, Gynecology ( Site 0714)
πΊπΈSeattle, Washington, United States
Well Pharma Medical Research, Corp. ( Site 0703)
πΊπΈMiami, Florida, United States
New Horizon Research Center ( Site 0717)
πΊπΈMiami, Florida, United States
Women Partners in Health ( Site 0745)
πΊπΈAustin, Texas, United States
Advanced Pharma Research ( Site 0719)
πΊπΈCutler Bay, Florida, United States
Synexus ( Site 0734)
πΊπΈScottsdale, Arizona, United States
HD Research Corp ( Site 0738)
πΊπΈHouston, Texas, United States
Hospital San Juan de Dios de La Serena ( Site 0110)
π¨π±La Serena, Region De Coquimbo, Chile
SPL Chorob Kobiecych i PoΕoznictwa dr L. Kobielska ( Site 0339)
π΅π±Katowice, Poland
Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
π΅π±Katowice, Poland
Uromed LLC ( Site 0410)
π·πΊSmolensk, Russian Federation
Hospital Sanitas La Moraleja ( Site 0504)
πͺπΈMadrid, Spain
GI Institute of POG of NAMS of Ukraine ( Site 0905)
πΊπ¦Kyiv, Ukraine
Medical Center Verum ( Site 0900)
πΊπ¦Kyiv, Ukraine
Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)
πΊπ¦Zaporizhzhya, Ukraine
Corpus Christi Clinic ( Site 0744)
πΊπΈCorpus Christi, Texas, United States
Carolina Women's Research and Wellness Center ( Site 0715)
πΊπΈDurham, North Carolina, United States
Paratus Clinical Kanwal ( Site 0004)
π¦πΊKanwal, New South Wales, Australia
Keogh Institute for Medical Research ( Site 0002)
π¦πΊNedlands, Western Australia, Australia
QPS Miami Research Associates ( Site 0735)
πΊπΈSouth Miami, Florida, United States
Examen Sp. z o.o. ( Site 0318)
π΅π±Skorzewo, Poland
Holdsworth House Medical Practice ( Site 0009)
π¦πΊSydney, New South Wales, Australia
Clinical Research Partners, LLC. ( Site 0704)
πΊπΈRichmond, Virginia, United States
Royal Adelaide Hospital ( Site 0007)
π¦πΊAdelaide, South Australia, Australia
PI-Coor Clinical Research, LLC ( Site 0710)
πΊπΈReston, Virginia, United States
Clinica Indisa [Santiago, Chile] ( Site 0101)
π¨π±Santiago, Chile
Royal Hospital for Women ( Site 0008)
π¦πΊRandwick, New South Wales, Australia
Southern Clinical Trials - Waitemata ( Site 0200)
π³πΏAuckland, New Zealand
Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
π΅π±Bialystok, Poland
LIFTMED ( Site 0325)
π΅π±Rybnik, Poland
Clinical Best Solutions ( Site 0338)
π΅π±Warszawa, Poland
Genes Fertility Institute Inc. ( Site 0803)
π΅π·San Juan, Puerto Rico
Gynecology & Endometriosis Center LLC ( Site 0806)
π΅π·San Juan, Puerto Rico
Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
πΊπ¦Zaporizhzhya, Ukraine
Communal Institution Maternity Hospital 3 ( Site 0909)
πΊπ¦Zaporizhzhya, Ukraine
Hospital Sanitas La Zarzuela ( Site 0502)
πͺπΈAravaca, Madrid, Spain
Hospital Clinic i Provincial de Barcelona ( Site 0501)
πͺπΈBarcelona, Spain
Instituto de Ciencias Medicas.ICM ( Site 0500)
πͺπΈAlicante, Spain
Alta California Medical Group ( Site 0721)
πΊπΈSimi Valley, California, United States
Artemis Institute for Clinical Research ( Site 0716)
πΊπΈSan Diego, California, United States
Cahaba Medical Care ( Site 0750)
πΊπΈBirmingham, Alabama, United States
California Center for Clinical Research ( Site 0741)
πΊπΈArcadia, California, United States
L&C Professional Medical Research Institute ( Site 0709)
πΊπΈMiami, Florida, United States