Trial · NCT03654326
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
NCT03654326, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2021-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034). Trials, record NCT03654326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03654326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
- NCT number
- NCT03654326
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 187 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Endometriosis-related Pain
- Interventions
- Gefapixant, Placebo, Naproxen
- First posted
- 2018-08-31
- Last updated
- 2024-11-04
- Other registries' IDs
- eudract:2018-001098-26
- Results first posted
- 2021-07-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | All randomized participants who received at least one dose of double-blind study intervention and had at least one day of eDiary entries during the post-randomization treatment cycle. | Scores on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced an Adverse Event | Up to approximately 10 weeks | All randomized participants who received at least one dose of study intervention. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to approximately 8 weeks | All randomized participants who received at least one dose of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | All randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available cyclic pelvic pain score data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | All randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available non-cyclic pelvic pain score data. | Scores on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 | Gefapixant | -2.2 | 95% Confidence Interval -2.79 to -1.62 | Scores on a Scale | |
| Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 | Placebo | -1.7 | 95% Confidence Interval -2.30 to -1.13 | Scores on a Scale | |
| Percentage of Participants Who Experienced an Adverse Event | Gefapixant | 53.2 | Percentage of Participants | ||
| Percentage of Participants Who Experienced an Adverse Event | Placebo | 35.5 | Percentage of Participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Gefapixant | 3.2 | Percentage of Participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Placebo | 0.0 | Percentage of Participants | ||
| Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2 | Gefapixant | -2.0 | 95% Confidence Interval -2.55 to -1.35 | Scores on a Scale | |
| Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2 | Placebo | -1.3 | 95% Confidence Interval -1.94 to -0.73 | Scores on a Scale | |
| Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2 | Gefapixant | -2.3 | 95% Confidence Interval -2.90 to -1.69 | Scores on a Scale | |
| Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2 | Placebo | -1.8 | 95% Confidence Interval -2.40 to -1.18 | Scores on a Scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gefapixant | 94 | |
| Overall Study | STARTED | Placebo | 93 | |
| Overall Study | COMPLETED | Gefapixant | 88 | |
| Overall Study | COMPLETED | Placebo | 87 | |
| Overall Study | NOT COMPLETED | Gefapixant | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant | 6 | 94 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 93 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Gefapixant | 6 | 94 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 2 | 93 | 2 |
| other | Ageusia | Nervous system disorders | Gefapixant | 9 | 94 | 9 |
| other | Ageusia | Nervous system disorders | Placebo | 1 | 93 | 1 |
| other | Dysgeusia | Nervous system disorders | Gefapixant | 15 | 94 | 16 |
| other | Dysgeusia | Nervous system disorders | Placebo | 2 | 93 | 2 |
| other | Headache | Nervous system disorders | Gefapixant | 4 | 94 | 4 |
| other | Headache | Nervous system disorders | Placebo | 7 | 93 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefapixant | 0 | 94 |
| Total, all-cause mortality | Placebo | 0 | 93 |
| Total, other adverse events | Gefapixant | 36 | 94 |
| Total, other adverse events | Placebo | 12 | 93 |
| Total, serious adverse events | Gefapixant | 0 | 94 |
| Total, serious adverse events | Placebo | 0 | 93 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39260540 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gefapixant vs Placebo: deaths from any cause | Trial comparisons |
| Gefapixant vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03654326
GET https://conductscience.org/api/trials/v1/NCT03654326/registered