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Completed

NCT Number: NCT03654326

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

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.

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Key information

Conditions

Endometriosis-related Pain

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Paratus Clinical Kanwal ( Site 0004), Kanwal, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gefapixant

Drug

Gefapixant tablet 45 mg taken orally

Other names: MK-7264

Placebo

Drug

Placebo matching gefapixant tablet taken orally

Naproxen

Drug

Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator

Primary outcomes

  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 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.

  2. 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.

  3. 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.

Secondary outcomes

  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 (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.

  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 (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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2018
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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