Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
ConditionErosive Esophagitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndonesia University
About this trial
The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Vonoprazan compare with Esomeprazole in improving early symptoms of erosive esophagitis patients in the Indonesian population?
Researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis.
Participants will:
* Take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks * Visit the clinic once every weeks for followup (Gastro Esophageal Reflux Disease-Quetionnaire measurement) * Keep a diary of their adverse effect occurence and every variable data based on Gastro Esophageal Reflux Disease-Questionnaire.
Eligibility criteria
Qualifiers
Patients aged >18 years with a GERD-Q score of 8.
Diagnosed with erosive esophagitis by endoscopy. (Los Angeles Classification A-D)
Patients are willing to undergo a series of therapeutic management.
Disqualifiers
Patients with a history of allergy to PCAB or PPI groups.
Patients with gastric and/or duodenal ulcers.
Patients with Helicobacter pylori infection.
Patients with a history of significant systemic disease disorders affecting the esophagus and stomach.
Trial design
Treatments tested in this trial
- Vonoprazan 20 mg
- Esomeprazole
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov