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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03654326




Registration number
NCT03654326
Ethics application status
Date submitted
17/08/2018
Date registered
31/08/2018

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
Scientific 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
Secondary ID [1] 0 0
2018-001098-26
Secondary ID [2] 0 0
7264-034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis-related Pain 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gefapixant
Treatment: Drugs - Placebo
Treatment: Drugs - Naproxen

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.

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.


Treatment: Drugs: Gefapixant
Gefapixant tablet 45 mg taken orally

Treatment: Drugs: Placebo
Placebo matching gefapixant tablet taken orally

Treatment: Drugs: Naproxen
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
Timepoint [1] 0 0
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event
Timepoint [2] 0 0
Up to approximately 10 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Timepoint [3] 0 0
Up to approximately 8 weeks
Secondary outcome [1] 0 0
Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
Timepoint [1] 0 0
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Secondary outcome [2] 0 0
Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
Timepoint [2] 0 0
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Paratus Clinical Kanwal ( Site 0004) - Kanwal
Recruitment hospital [2] 0 0
Royal Hospital for Women ( Site 0008) - Randwick
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice ( Site 0009) - Sydney
Recruitment hospital [4] 0 0
Royal Adelaide Hospital ( Site 0007) - Adelaide
Recruitment hospital [5] 0 0
Keogh Institute for Medical Research ( Site 0002) - Nedlands
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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North Carolina
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Chile
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Region De Coquimbo
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Chile
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Region Metropolitana
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Chile
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Santiago
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New Zealand
State/province [18] 0 0
Auckland
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New Zealand
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Christchurch
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Poland
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Bialystok
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Poland
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Katowice
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Poland
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Rybnik
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Poland
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Skorzewo
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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Bayamon
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Spain
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Madrid
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Spain
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Alicante
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Spain
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Barcelona
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Ukraine
State/province [38] 0 0
Ivano-Frankivsk
Country [39] 0 0
Ukraine
State/province [39] 0 0
Kyiv
Country [40] 0 0
Ukraine
State/province [40] 0 0
Odessa
Country [41] 0 0
Ukraine
State/province [41] 0 0
Ternopil
Country [42] 0 0
Ukraine
State/province [42] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03654326