Trial · NCT07010107
A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
NCT07010107, Phase 3, Recruiting, Xuanzhu Biopharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Anaprazole for Treating Reflux Esophagitis. Trials, record NCT07010107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07010107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
- NCT number
- NCT07010107
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Conditions
- Reflux Esophagitis (RE)
- Interventions
- Anaprazole + Rabeprazole placebo, Rabeprazole + Anaprazole placebo
- First posted
- 2025-06-08
- Last updated
- 2025-09-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The endoscopic healing rate of reflux esophagitis | Up to 8 weeks | The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification. |
| Secondary | The endoscopic healing rate of reflux esophagitis | Up to 4 weeks | The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification. |
| Secondary | Changes in the severity and frequency of heartburn compared to the baseline | Up to 8 weeks | The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of heartburn was evaluated using a 4-point scale, while the frequency of occurrence of heartburn was assessed using a 5-point scale. |
| Secondary | Changes in the severity and frequency of reflux compared to the baseline | Up to 8 weeks | The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of reflux was evaluated using a 4-point scale, while the frequency of occurrence of reflux was assessed using a 5-point scale. |
| Secondary | The rate of improvement in the severity and frequency of heartburn | Up to 8 weeks | Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%. |
| Secondary | The rate of improvement in the severity and frequency of reflux | Up to 8 weeks | Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%. |
| Secondary | Change from baseline in the Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL) score | Up to 8 weeks | GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline, Days 29 and 57 of treatment, and visits for early trial withdrawal. The scale contains 10 questions and a symptom control satisfaction survey, which focuses on heartburn, acid reflux, swallowing function, and drug efficacy. Each question is scored according to a 6-point scoring criterion (0 indicates no symptoms, 5 indicates intolerable symptoms, and affects daily activities), and the total score is the sum of the scores of each item (0-50 points in total), with higher scores indicating worse quality of life. Satisfaction is divided into three levels: dissatisfaction, moderate, and satisfaction. Change in GERD-HRQL score = total GERD-HRQL score after treatment - total GERD-HRQL score before treatment. |
| Secondary | Adverse events | Up to 8 weeks | The treatment-emergent adverse events are evaluated by CTCAE v5.0 |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07010107
GET https://conductscience.org/api/trials/v1/NCT07010107/registered