RecruitingPhase 4NCT06564246

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


Sponsor

Tanta University

Enrollment

44 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.


Eligibility

Min Age: 17 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

DRUGVonoprazan 20 mg versus Pantoprazole 40 mg

Patients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole


Locations(1)

Theodore Billiharz Institute for Researchs

Giza, Egypt

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NCT06564246


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