Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

NCT06720610 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: INVEST0124-08-1382
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

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.

Conditions

Erosive Esophagitis

Keywords

erosive esophagitis; vonoprazan; esomeprazole; gerd-q

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Adverse Event

  14 days (two weeks)

Other Outcomes (1)

• Rate of Drug Compliance

  14 days (two weeks)

Study Arms (2)

Vonoprazan

EXPERIMENTAL

Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively

Drug: Vonoprazan 20 mg

Esomeprazole

ACTIVE COMPARATOR

Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively

Drug: Esomeprazole

Interventions

Vonoprazan 20 mg DRUG

Vonoprazan PO, 20mg, once a day, 14 days.

Also known as: vocinti

Vonoprazan

Esomeprazole DRUG

Esomeprazole PO, 40mg, once a day, 14 days

Also known as: Esomeprazole generic

Esomeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (5)

Hermina Jatinegara Hospital

East Jakarta, DKI Jakarta, 13320, Indonesia

Location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Hermina Kemayoran Hospital

Jakarta Pusat, DKI Jakarta, 10620, Indonesia

Location

Hermina Bekasi Hospital

Bekasi, West Java, 17141, Indonesia

Location

Hermina Depok Hospital

Depok, West Java, 16436, Indonesia

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ari F Syam, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari F Syam, MD

CONTACT

+62818706199; ari_syam@hotmail.com

Ryan Herardi, MD

CONTACT

+6281381166910; dr.ryanherardi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Faculty of Medicine Universitas Indonesia

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 9, 2024
• Primary Completion: April 25, 2025
• Study Completion: June 27, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (5)