Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis (INVEST)

Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: Vonoprazan 20 mg; Drug: Esomeprazole

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ari F Syam, MD; Phone Number: +62818706199; Email: ari_syam@hotmail.com
• Study Contact Backup: Name: Ryan Herardi, MD; Phone Number: +6281381166910; Email: dr.ryanherardi@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • East Jakarta, DKI Jakarta, Indonesia, 13320
      • Hermina Jatinegara Hospital
      • Contact: Arlyando Saragih, MD; Phone Number: +628128225640; Email: arlyando2020@gmail.com
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital
      • Contact: Ryan Herardi, MD; Phone Number: +6281381166910; Email: dr.ryanherardi@gmail.com
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10620
      • Hermina Kemayoran Hospital
      • Contact: Andry Kurniawan, MD; Phone Number: +628126729703; Email: andreedoc85@gmail.com
  • Jawa Barat
    • Bekasi, Jawa Barat, Indonesia, 17141
      • Hermina Bekasi Hospital
      • Contact: Nikko Darnindro, MD; Phone Number: +628129734458; Email: nikkodarnindro@gmail.com
    • Depok, Jawa Barat, Indonesia, 16436
      • Hermina Depok Hospital
      • Contact: Aru Ariadno, MD; Phone Number: +6281384473476; Email: roeariadno@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan; Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively	Drug: Vonoprazan 20 mg; Vonoprazan PO, 20mg, once a day, 14 days.; Other Names: vocinti
Active Comparator: Esomeprazole; Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively	Drug: Esomeprazole; Esomeprazole PO, 40mg, once a day, 14 days; Other Names: Esomeprazole generic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Symptoms Resolution of Erosive Esophagitis	Participants achieved a,; complete resolution if they scored a GERD-Q questionnaire of 0 from scale 0-18. - sufficient relief if they scored GERD-Q of 1 or 0 (No. 1,2,5,6); persistent response if they score GERD-Q of 2 or more in any single question.	14 days (two weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Event	Yes: nasopharyngitis, diarrhea, acute upper respiratory infection, lower back pain, constipation No: none of any	14 days (two weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Drug Compliance	Compliant (14 drugs finished in 14 days) Lack of compliance (14 drugs finished in >14 days) Non-compliant (not taking drugs)	14 days (two weeks)

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Ari F Syam, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Estimated): December 9, 2024
• Primary Completion (Estimated): April 25, 2025
• Study Completion (Estimated): June 27, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: esomeprazole; vonoprazan; erosive esophagitis; gerd-q
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: INVEST01; 24-08-1382 (Other Identifier: The Ethics Commitee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No