Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 24-08-1382 | Other Identifier | The Ethics Commitee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan | Experimental | Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively |
|
| Esomeprazole | Active Comparator | Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan 20 mg | Drug | Vonoprazan PO, 20mg, once a day, 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Symptoms Resolution of Erosive Esophagitis | Participants achieved a,
| 14 days (two weeks) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ari F Syam, MD | Contact | +62818706199 | ari_syam@hotmail.com | |
| Ryan Herardi, MD | Contact | +6281381166910 | dr.ryanherardi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ari F Syam, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hermina Jatinegara Hospital | East Jakarta | DKI Jakarta | 13320 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Esomeprazole | Drug | Esomeprazole PO, 40mg, once a day, 14 days |
|
|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
|
| Hermina Kemayoran Hospital | Jakarta Pusat | DKI Jakarta | 10620 | Indonesia |
|
| Hermina Bekasi Hospital | Bekasi | West Java | 17141 | Indonesia |
|
| Hermina Depok Hospital | Depok | West Java | 16436 | Indonesia |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |