Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease

Launched by TANTA UNIVERSITY · Aug 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications, vonoprazan and pantoprazole, to see which one works better for people with gastroesophageal reflux disease (GERD), a condition where stomach acid frequently flows back into the esophagus, causing discomfort. The study is currently looking for participants aged 17 to 60 years who have been diagnosed with GERD, meaning they have a specific score of 8 or higher on a GERD questionnaire.

Eligible participants will not have any serious gastrointestinal issues or certain other health conditions that could interfere with the study, such as heart or kidney problems. If you join the trial, you will be assessed at the start and then again after eight weeks to see how well the medication is working for you. This research aims to provide more information about effective treatments for GERD, which could help many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.