Comparing Vonoprazan and Pantoprazole for Treating GERD
Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
This study tests whether a new medication called vonoprazan works better than pantoprazole for treating GERD symptoms in adults aged 17 to 60.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 17 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06564246 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the efficacy of vonoprazan compared to pantoprazole in patients diagnosed with gastroesophageal reflux disease (GERD). The study focuses on patients aged 17 to 60 years who exhibit significant GERD symptoms, as measured by the Gastroesophageal Reflux Disease Questionnaire. Participants will receive either vonoprazan 20 mg or pantoprazole 40 mg for a duration of 8 weeks, with the primary goal of improving their quality of life by alleviating symptoms. The study aims to provide insights into the effectiveness of these two medications in managing GERD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 17-60 years with a GERD score of 8 or higher on the Gastroesophageal Reflux Disease Questionnaire.
Not a fit: Patients with a history of gastrointestinal diseases, certain surgical histories, or other specified medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from GERD, enhancing their quality of life.
How similar studies have performed: Other studies have shown varying degrees of success with proton pump inhibitors, but the specific comparison of vonoprazan to pantoprazole in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Giza
- Theodore Billiharz Institute for Researchs — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Aya Hany Abdel Aziz — Master degree student at faculty of pharmacy - Tanta university
- Study coordinator: Aya Hany Abdel Aziz, Bachelor
- Email: PG_172956@pharm.tanta.edu.eg
- Phone: +201144818823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.