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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Vonoprazan 20 mg
Drug
Vonoprazan PO, 20mg, once a day, 14 days.
Esomeprazole
Drug
Esomeprazole PO, 40mg, once a day, 14 days

Treatment groups

216 Participants

are divided into 2 treatment groups

Group A: VonoprazanExperimental treatment 1 intervention

Group B: EsomeprazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

14 days (two weeks)

Secondary outcomes

Number of Participants with Adverse Event

Yes: nasopharyngitis, diarrhea, acute upper respiratory infection, lower back pain, constipation No: none of any

Time frame

14 days (two weeks)

Other outcomes

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)

Time frame

14 days (two weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: