Trial · NCT07326904
Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease
NCT07326904, Phase 3, Completed, Universitas Indonesia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease. Trials, record NCT07326904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07326904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease
- NCT number
- NCT07326904
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 145 participants, actual
- Lead sponsor
- Universitas Indonesia
- Conditions
- Gastro Oesophageal Reflux Disease
- Interventions
- Fexuprazan, Esomeprazole
- First posted
- 2026-01-08
- Last updated
- 2026-08-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8) | 4 weeks | Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score \<8 at Week 4, indicating adequate relief of GERD symptoms. |
| Secondary | Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8) | 8 weeks | The proportion of participants who achieved symptom relief at Week 8, defined as a total score of less than 8 on the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater symptom severity). This assessment applied only to participants who continued treatment beyond the initial 4-week period. |
| Secondary | Time to Complete Symptom Response After First Dose | From first dose until achievement of complete response, up to 8 weeks | Complete response was defined as the absence of heartburn and/or acid regurgitation symptoms for 7 consecutive days based on patient diaries. Time to complete response was measured in days from the first dose to the first day of the 7-day symptom-free period. Analysis included all subjects using time-to-event methods. |
| Secondary | Number of Participants Without Major GERD Symptoms | Up to 8 weeks | The number of participants without major GERD symptoms (heartburn and/or acid regurgitation) during predefined periods, including the first 7 days, 4 weeks, and 8 weeks after initiation of treatment, as recorded in participant diaries. |
| Secondary | Percentage of Days Free of Major GERD Symptoms | Up to 8 weeks | The percentage of days without heartburn and/or acid regurgitation per participant during the first 7 days, 4 weeks, and 8 weeks after treatment initiation. This includes daytime, nighttime, and combined daytime/nighttime periods based on participant diary entries, analyzed and reported as the mean percentage of symptom-free days |
| Secondary | Change From Baseline in GERD-Q Total Score | Baseline up to 8 weeks (Evaluated at 7 days, 4 weeks, and 8 weeks) | Change from baseline in the Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score. The GERD-Q is a 6-item scale used to evaluate the frequency of GERD symptoms. Total scores range from a minimum of 0 to a maximum of 18, where higher scores indicate greater symptom severity (a worse outcome). |
| Secondary | Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score | Baseline to up to 8 weeks | Change from baseline in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score. The GERD-HRQL is a 10-item instrument used to assess the impact of symptoms on daily life. Total scores range from a minimum of 0 to a maximum of 50, where higher scores indicate worse health-related quality of life (a worse outcome). |
| Other | Number of Participants With Relief From Chronic Cough | Up to 8 weeks | The number of participants who experienced relief from chronic cough symptoms during predefined periods after initiation of study treatment, based on participant diary assessments. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom of chronic cough at baseline, while all post-baseline time points report the number of participants that experienced symptom relief. |
| Other | Number of Participants With Relief of Throat Irritation Sensation | Up to 8 weeks | The number of participants who experienced relief of throat irritation or foreign body sensation during predefined periods after initiation of study treatment, as recorded in participant diaries. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief. |
| Other | Number of Participants Without Nocturnal GERD Symptoms | Up to 8 weeks | The number of participants who were not awakened from sleep due to heartburn or acid regurgitation during predefined periods after initiation of study treatment, as recorded in participant diaries. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers26
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07326904
GET https://conductscience.org/api/trials/v1/NCT07326904/papers?page=2