A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
ConditionReflux Esophagitis (RE)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuanzhu Biopharmaceutical Co., Ltd.
About this trial
This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.
Eligibility criteria
Qualifiers
The patients provided voluntary signed informed consent forms.
Aged ≥18 years and ≤75 years old.
Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.
Disqualifiers
Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems.
Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.
Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
Trial design
Treatments tested in this trial
- Anaprazole + Rabeprazole placebo
- Rabeprazole + Anaprazole placebo
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov