Clinical trial NCT06720610: Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
Official title: Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Erosive Esophagitis
Keywords: erosive esophagitis
vonoprazan
esomeprazole
gerd-q
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. Considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. Therefore, the total minimum sample required for this study is 216 samples for both groups.

All the patients will screened using the Gastro Esophageal Reflux Disease-Quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through RedCap. After that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists.

Included patients who consume any Proton Pump Inhibiotr or Potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. Patients are monitored weekly during the wash-out period. Medication reminders are sent via instant messaging at least twice per week. Adverse Event will be monitored by research assistants in coordination with the patient's primary physician.

All the data will analyzed blindly with Chi-square or Fisher's exact test for categorical data and logistic regression for confounding factors. At the end of the study, the pharmacy team will reveal the group allocation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Patients with a history of malignant disease related to the esophagus and/or stomach.
* Patients with a history of esophageal and/or gastric surgery.
* Pregnant patients

Primary outcomes:
measure: Number of Participants with Symptoms Resolution of Erosive Esophagitis
timeFrame: 14 days (two weeks)
Secondary outcomes:
measure: Number of Participants with Adverse Event
timeFrame: 14 days (two weeks)
Other outcomes:
measure: Rate of Drug Compliance
timeFrame: 14 days (two weeks)
Locations:
city: East Jakarta
country: Indonesia
facility: Hermina Jatinegara Hospital
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Hermina Kemayoran Hospital
state: DKI Jakarta
city: Bekasi
country: Indonesia
facility: Hermina Bekasi Hospital
state: Jawa Barat
city: Depok
country: Indonesia
facility: Hermina Depok Hospital
state: Jawa Barat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Ari F Syam, MD
role: PRINCIPAL_INVESTIGATOR
References: