Reflux EsophagitisPhase 2NCT05604261
A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis
A Phase 2 study testing Anaprazole sodium 40 mg, Anaprazole sodium 60 mg and Rabeprazole sodium 20 mg in people with Reflux Esophagitis and Gastroesophageal Reflux, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A phase 2, randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter trial to evaluate efficacy and safety of within 8 weeks (including 8 weeks) treatment of Anaprazole 40mg QD, 60mg QD compared with Rabeprazole 20mg QD in patients with reflux esophagitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis
- What is being tested?
- Anaprazole sodium 40 mg, Anaprazole sodium 60 mg and Rabeprazole sodium 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects clearly understand and voluntarily participate in this study, sign the informed consent form and voluntarily comply with the study procedures;
- Age ≥ 18 years and ≤ 70 years, male or female;
- Endoscopic diagnosis of reflux esophagitis (LA classification criteria grades A-D) within 7 days prior to randomization.
Who cannot join
- Subjects who meet any of the following criteria will not be allowed to participate in this study:
- Past medical history
- Subjects whose primary diseases that are not suitable for participating in the clinical trial cannot be effectively controlled in the investigator 's opinion, such as patients with previous severe heart, brain, lung, liver, kidney and other systemic diseases;
- Patients with previous concomitant diseases that may affect esophageal motility or motility, which may still affect the efficacy evaluation (e.g., eosinophilic esophagitis, esophageal varices, scleroderma, viral infection or fungal infection, esophageal stenosis, etc.) at the investigator 's discretion, or with a history of esophageal radiotherapy or esophageal cryotherapy;
- History of previous surgical procedures that could affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures), or history of gastric or duodenal surgery, excluding endoscopic removal of benign polyps;
- Subjects with active peptic ulcer, active upper/lower gastrointestinal bleeding confirmed by esophagogastroduodenoscopy (EGD) within 30 days prior to randomization;
Show all 19Show fewer
- Subjects with previous Zollinger-Ellison syndrome, achalasia, secondary esophageal motility disorder, irritable bowel syndrome, inflammatory bowel disease;
- Prior malignancy or treatment for malignancy within 5 years prior to randomization (except cured cutaneous basal cell carcinoma or cervical carcinoma in situ);
- Subjects who have a previous history of psychiatric disorders (except for patients with current psychiatric disorders who are stable and not under medication control as judged by the investigator), or a history of drug or alcohol abuse within 12 months prior to Screening.
- General/Laboratory Tests
- Abnormal liver function at screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.5 × ULN and/or total bilirubin (TBIL) ≥ 1.5 × ULN;
- Abnormal renal function at screening: serum creatinine (Cr) ≥ 1.2 × ULN/blood urea nitrogen (BU)/blood urea nitrogen (BUN) ≥ 1.2 × ULN; Other conditions
- Patients unable to undergo esophagogastroduodenoscopy (EGD);
- Patients who are allergic to Annarazole Sodium or Rabeprazole Sodium and other drug ingredients or components that may be used in the study;
- Use of therapeutic doses of drugs for gastroesophageal reflux disease such as proton pump inhibitors, potassium-competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs, prokinetic drugs, anti-Helicobacter pylori drugs, and Chinese patent medicines for gastroesophageal reflux disease within 7 days before randomization;
- Subjects who may affect the efficacy and safety evaluation due to alcohol, drug and drug withdrawal during the study;
- Pregnant or lactating women, subjects with fertility plan from 30 days before randomization to half a year after the end of the trial;
- Participation in another drug clinical trial (defined as receiving investigational product or placebo) within 3 months prior to randomization;
- Other conditions that the investigator considers the subject unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhaoshen Li, 021-55621735, zhaoshen-li@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis
A phase 2, randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter trial to evaluate efficacy and safety of within 8 weeks (including 8 weeks) treatment of Anaprazole 40mg QD, 60mg QD compared with Rabeprazole 20mg QD in patients with reflux esophagitis.
Read the detailed description
This is a multicenter, randomized, double-blind, double-dummy, active drug-parallel-controlled, phase 2 clinical study to evaluate the efficacy and safety of Anaprazole Sodium 40 mg QD and 60 mg QD versus Rabeprazole Sodium 20 mg QD in the treatment of reflux esophagitis in Chinese subjects with reflux esophagitis. The target population for this study was subjects with endoscopically confirmed reflux esophagitis. All potential participants will provide informed consent, and those who provide informed consent will enter the Screening Period (Day -7 to Day -1) and be assessed for screening eligibility according to the inclusion and exclusion criteria. The study is expected to enroll approximately 156 subjects with reflux esophagitis (LA classification grades A-D) who meet enrollment criteria (and none of the exclusion criteria), and eligible subjects will be randomized into 3 groups (Anaprazole Sodium 40 mg QD, 60 mg QD, and Rabeprazole Sodium 20 mg QD) in a 1:1: 1 ratio according to a predefined randomization table, with 52 subjects in each group. All subjects take the corresponding study drug within 30-60 minutes before breakfast for 4 or 8 consecutive weeks (subjects were followed up at Week 4 of treatment, and if the subject'endoscopy indicated that the reflux esophagitis was healed, the healed subject ended study treatment and entered safety follow-up. Subjects who were not cured were to continue treatment until 8 weeks if endoscopy at 4 weeks of treatment indicated that reflux esophagitis was not cured.). All subjects complete treatment at 4 or 8 weeks of treatment and were followed for safety. At the end of the study, statistical analysis will be performed on the efficacy and safety indicators of the study drug to compare the efficacy and safety of Anaprazole sodium and rabeprazole sodium in the treatment of reflux esophagitis. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 3 groups. Participants' safety will be monitored throughout the study.
- Conditions
- Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases
- Being tested
- Anaprazole sodium 40 mg, Anaprazole sodium 60 mg, Rabeprazole sodium 20 mg
- Keywords
- Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux, Esophagitis, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaprazole sodium 40 mgDrug
Anaprazole sodium 2 tablets (20 mg/tablet) + Anaprazole sodium dummy tablets 1 tablet (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).
Anaprazole sodium 60 mgDrug
Anaprazole sodium 3 tablets (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).
Rabeprazole sodium 20 mgDrug
Anaprazole sodium dummy tablets 3 tablets (20 mg/tablet) + Rabeprazole sodium 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).
| Study group | Role | What they receive |
|---|---|---|
| Anaprazole sodium 40 mg QD | Experimental | Not described Receives: Drug: Anaprazole sodium 40 mg |
| Anaprazole sodium 60 mg QD | Experimental | Not described Receives: Drug: Anaprazole sodium 60 mg |
| Rabeprazole sodium 20 mg QD | Active comparator | Not described Receives: Drug: Rabeprazole sodium 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endoscopic healing rate of reflux esophagitis within 8 weeks (including 8 weeks)
The endoscopic ulcer healing rate is defined as the percentage of patients with reflux esophagitis healed evaluated by blinded independency central reading. Reflux esophagitis is evaluated by endoscopy as per LA Classification.
Measured: Treatment of 4 weeks or 8 weeks
Secondary outcomes (6)
The rate of improvement in each individual symptom (daytime reflux)
The assessment of improvement of daytime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded.
Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Measured: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (daytime heartburn)
The assessment of improvement of daytime heartburn is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded.
Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Measured: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (nighttime reflux)
The assessment of improvement of nighttime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded.
Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Measured: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (nighttime heartburn)
The assessment of improvement of nighttime heartburn is evaluated in terms of severity and frequency of each of the four individual symptoms. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded.
Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Measured: Treatment of 4 weeks or 8 weeks
Change From Baseline in gastroesophageal reflux disease health-related quality of life scale (GERD-HRQL) score
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 and at six months after treatment. 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 scoring criteria of 6 scores (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.
Measured: Treatment of 4 weeks or 8 weeks
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604261
- Sponsor's protocol ID
- 3571-RE-2001
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT05604261
- Acronym / sponsor ID
- 3571-RE-2001
- Conditions
- Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases
- Keywords
- Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2, randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter trial to evaluate efficacy and safety of within 8 weeks (including 8 weeks) treatment of Anaprazole 40mg QD, 60mg QD compared with Rabeprazole 20mg QD in patients with reflux esophagitis.
Detailed description
This is a multicenter, randomized, double-blind, double-dummy, active drug-parallel-controlled, phase 2 clinical study to evaluate the efficacy and safety of Anaprazole Sodium 40 mg QD and 60 mg QD versus Rabeprazole Sodium 20 mg QD in the treatment of reflux esophagitis in Chinese subjects with reflux esophagitis. The target population for this study was subjects with endoscopically confirmed reflux esophagitis. All potential participants will provide informed consent, and those who provide informed consent will enter the Screening Period (Day -7 to Day -1) and be assessed for screening eligibility according to the inclusion and exclusion criteria. The study is expected to enroll approximately 156 subjects with reflux esophagitis (LA classification grades A-D) who meet enrollment criteria (and none of the exclusion criteria), and eligible subjects will be randomized into 3 groups (Anaprazole Sodium 40 mg QD, 60 mg QD, and Rabeprazole Sodium 20 mg QD) in a 1:1: 1 ratio according to a predefined randomization table, with 52 subjects in each group. All subjects take the corresponding study drug within 30-60 minutes before breakfast for 4 or 8 consecutive weeks (subjects were followed up at Week 4 of treatment, and if the subject'endoscopy indicated that the reflux esophagitis was healed, the healed subject ended study treatment and entered safety follow-up. Subjects who were not cured were to continue treatment until 8 weeks if endoscopy at 4 weeks of treatment indicated that reflux esophagitis was not cured.). All subjects complete treatment at 4 or 8 weeks of treatment and were followed for safety. At the end of the study, statistical analysis will be performed on the efficacy and safety indicators of the study drug to compare the efficacy and safety of Anaprazole sodium and rabeprazole sodium in the treatment of reflux esophagitis. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 3 groups. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anaprazole sodium 40 mg QD | Experimental | Drug: Anaprazole sodium 40 mg |
| Anaprazole sodium 60 mg QD | Experimental | Drug: Anaprazole sodium 60 mg |
| Rabeprazole sodium 20 mg QD | Active comparator | Drug: Rabeprazole sodium 20 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects clearly understand and voluntarily participate in this study, sign the informed consent form and voluntarily comply with the study procedures;
- Age ≥ 18 years and ≤ 70 years, male or female;
- Endoscopic diagnosis of reflux esophagitis (LA classification criteria grades A-D) within 7 days prior to randomization.
Key exclusion criteria (19 listed)
- Subjects who meet any of the following criteria will not be allowed to participate in this study:
- Past medical history
- Subjects whose primary diseases that are not suitable for participating in the clinical trial cannot be effectively controlled in the investigator 's opinion, such as patients with previous severe heart, brain, lung, liver, kidney and other systemic diseases;
- Patients with previous concomitant diseases that may affect esophageal motility or motility, which may still affect the efficacy evaluation (e.g., eosinophilic esophagitis, esophageal varices, scleroderma, viral infection or fungal infection, esophageal stenosis, etc.) at the investigator 's discretion, or with a history of esophageal radiotherapy or esophageal cryotherapy;
- History of previous surgical procedures that could affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures), or history of gastric or duodenal surgery, excluding endoscopic removal of benign polyps;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anaprazole sodium 40 mgAnaprazole sodium 2 tablets (20 mg/tablet) + Anaprazole sodium dummy tablets 1 tablet (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period). | Drug | Anaprazole sodium 40 mg QD |
| Anaprazole sodium 60 mgAnaprazole sodium 3 tablets (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period). | Drug | Anaprazole sodium 60 mg QD |
| Rabeprazole sodium 20 mgAnaprazole sodium dummy tablets 3 tablets (20 mg/tablet) + Rabeprazole sodium 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period). | Drug | Rabeprazole sodium 20 mg QD |
Primary outcome
The endoscopic healing rate of reflux esophagitis within 8 weeks (including 8 weeks)
Time frame: Treatment of 4 weeks or 8 weeks
The endoscopic ulcer healing rate is defined as the percentage of patients with reflux esophagitis healed evaluated by blinded independency central reading. Reflux esophagitis is evaluated by endoscopy as per LA Classification.
6 secondary outcomes
The rate of improvement in each individual symptom (daytime reflux)
Time frame: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (daytime heartburn)
Time frame: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (nighttime reflux)
Time frame: Treatment of 4 weeks or 8 weeks
The rate of improvement in each individual symptom (nighttime heartburn)
Time frame: Treatment of 4 weeks or 8 weeks
Change From Baseline in gastroesophageal reflux disease health-related quality of life scale (GERD-HRQL) score
Time frame: Treatment of 4 weeks or 8 weeks
Adverse events
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anaprazole sodium 40 mg, Anaprazole sodium 60 mg and Rabeprazole sodium 20 mg in people with Reflux Esophagitis and Gastroesophageal Reflux, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaping Luo (15367827140, luoyaping@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endoscopic healing rate of reflux esophagitis within 8 weeks (including 8 weeks) (time frame: Treatment of 4 weeks or 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.