Status:
RECRUITING
Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
Lead Sponsor:
Tanta University
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
17-60 years
Phase:
PHASE4
Brief Summary
This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.
Detailed Description
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the esophagus with or without histological changes. However, the excessive reflux of gastric acid induces som...
Eligibility Criteria
Inclusion
- Age 17-60 years.
- Both genders.
- Patients with a score ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (Gerd Q) are defined as having GERD and will enroll in this study and it will be done at baseline and after 8 weeks.
Exclusion
- Subjects with history of gastrointestinal disease, gastroduodenal surgery, inflammatory bowel disease and Barrett's esophagus.
- Subjects with an earlier or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders (gastric or duodenal ulcer).
- Subjects with history of total/subtotal gastrectomy and esophageal achalasia.
- Subjects with Corona virus disease (COVID19).
- Subjects with major cardiological, respiratory, endocrine metabolic disease and neuro-psychological disease.
- Pregnancy or lactation.
- Subjects with total bilirubin level ≥ 1.2 mg/dl and ALT level \> 100 IU/l.
- Subjects with renal impairment (Crcl less than 30 ml/min).
- Patients receiving atazanavir sulphate, nelfinavir and rilpivirine hydrochloride due to potential drug interactions.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06564246
Start Date
September 18 2024
End Date
October 1 2026
Last Update
December 5 2024
Active Locations (1)
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1
Theodore Billiharz Institute for Researchs
Giza, Egypt