A Phase 4 interventional study of Vonoprazan 20 mg and Esomeprazole in Erosive Esophagitis, sponsored by Indonesia University. Not yet recruiting at 5 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Indonesia University · Phase 4, Interventional, and Treatment
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:
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.
123 studies on the registry are indexed under Esophagitis; 15 are open to participants now.
This study's planned enrollment of 216 is above the median of 96 across 99 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively
Drug: Vonoprazan 20 mg
Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively
Drug: Esomeprazole
Vonoprazan PO, 20mg, once a day, 14 days.
Also known as: vocinti
Esomeprazole PO, 40mg, once a day, 14 days
Also known as: Esomeprazole generic
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)
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)
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)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Apr 2025, 4 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vonoprazan