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

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ClinicalTrials.gov Identifier: NCT03654326
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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) during Treatment Cycle 2.

Condition or disease Intervention/treatment Phase
Endometriosis-related Pain Drug: Gefapixant Drug: Placebo Drug: Naproxen Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : June 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gefapixant
Participants will receive a gefapixant tablet twice a day for 8 weeks. Naproxen sodium tablets will also be provided to participants for use as rescue medication for endometriosis-related pain.
Drug: Gefapixant
Gefapixant tablet taken orally
Other Name: MK-7264

Drug: Placebo
Placebo matching gefapixant tablet taken orally

Drug: Naproxen
Naproxen sodium tablets taken orally as needed.

Placebo Comparator: Placebo
Participants will receive a placebo matching gefapixant tablet twice a day for 8 weeks. Naproxen sodium 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 tablets taken orally as needed.




Primary Outcome Measures :
  1. 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 and non-cyclic) severity will be measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The average of the daily pelvic pain scores (cyclic and non-cyclic) entered in the eDiary will be calculated for the Baseline and for Treatment Cycle 2 (Week 4 to Week 8).

  2. Adverse Events [ Time Frame: Up to 12 weeks ]
    The number of participants experiencing one or more adverse events will be reported.

  3. Treatment Discontinuations Due to Adverse Events [ Time Frame: Up to 8 weeks ]
    The number of participants discontinuing study drug due to an adverse event will be reported.


Secondary Outcome Measures :
  1. 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 severity will be 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 the eDiary will be calculated for the Baseline and for Treatment Cycle 2 (Week 4 to Week 8).

  2. 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 severity will be 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 the eDiary will be calculated for the Baseline and for the Treatment Cycle 2 (Week 4 to Week 8).



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis.
  • has cyclic AND non-cyclic, moderate to severe endometriosis-related pelvic 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654326


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03654326     History of Changes
Other Study ID Numbers: 7264-034
2018-001098-26 ( EudraCT Number )
MK-7264-034 ( Other Identifier: Merck Protocol Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action