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IRCT20251101067844N1 IRCT 2026-01-13 Abidi Pharmaceutical company A Comparative Study of Vonoprazan and Pantoprazole in the Treatment of NERD and Erosive Esophagitis Comparison of the Effectiveness and Adverse Effects of Phorize (Vonoprazan) Versus Pantoprazole in Controlling Symptoms of Non-Erosive Reflux Disease (NERD) and Clinical Improvement of Erosive Esophagitis (EE) 2026-01-21 anticipated 730 Recruiting https://irct.ir/trial/87527 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed Envelope Ltd.2024 software was used. In the erosive esophagitis arm, a total of 438 patients were numbered. Randomization was performed in blocks of 4 in a 1:1 ratio by assigning 3-letter codes consisting of numbers and Latin letters to the patient numbers. Accordingly, half of the patients will receive venoprazan and the other half will receive pantoprazole. In the non-erosive reflux disease arm, a total of 292 patients were numbered. In blocks of 4 in a 1:1 ratio, randomization was performed by assigning 3-letter codes consisting of numbers and Latin letters to the patient numbers. Accordingly, half of the patients will receive venoprazan and the other half will receive pantoprazole. The list of codes assigned to each patient in both study arms is kept in separate Excel files only accessible to the epidemiologist and study executive director and will not be made available to the treatment centers or patients, Blinding description: Patients will be informed that they will be given one of two gastroesophageal reflux disease treatments, pantoprazole or vonoprazan, and that the type of medication assigned will not be known until the end of the study. In both study arms, medications were packaged in unlabeled, sealed, single-color bottles. The required medication bottles were placed in identical paper envelopes. The patient number and assigned randomization code were affixed to the bottle and the paper envelope. According to the instructions sent to the patient admission centers, in both study arms, patient admission will be done by number and in order. Therefore, patients and admission centers are blinded to the assigned medication. 3 Gastro-esophageal Reflux Disease. Intervention 1: Intervention group one: Erosive Esophagitis (EE), Vonoprazan Arm, Participants will receive vonoprazan (phorize, Abidi) 20 milligrams tablets once daily for 8 weeks as initial treatment, followed by vonoprazan 10 miligrams tablets once daily for 16 weeks as maintenance treatment. Intervention 2: Intervention group two: Erosive Esophagitis (EE), Pantoprazole Arm, Participants will receive pantoprazole (Pentomid, Tehran Shimi) 40 milligrams once daily, taken before breakfast, followed by Pentomid 20 milligrams before breakfast for 16 weeks. Intervention 3: Intervention Group three: Non-Erosive Reflux Disease (NERD), Vonoprazan Arm, Participants will receive vonoprazan (phorize, Abidi) 10 milligrams tablets once daily for 8 weeks. Intervention 4: Intervention Group four: Non-Erosive Reflux Disease (NERD), Pantoprazole Arm, Participants will receive pantoprazole (Pentomid, Tehran Shimi) 20 milligram tablets once daily, taken before breakfast for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Shahram Agah
Rasoul Akram hosptial, Niyayesh st., Sattarkhan st.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2358 shahram.agah@isge.ir Iran University of Medical Sciences scientific Shahram Agah
Rasoul Akram hosptial, Niyayesh st., Sattarkhan st.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2358 shahram.agah@isge.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) diagnosis of Non-Erosive Reflux Disease (NERD) or Erosive Esophagitis (EE) based on endoscopy, with any severity level requiring pharmacologic treatment Patients diagnosed with NERD or EE by an experienced and active endoscopist within the past 6 months. 18 years no limit Both Refractory erosive esophagitis or previous failure to respond to treatment with proton pump inhibitors History of fundoplication surgery or gastrectomy. History of Barrett’s esophagus or esophageal dysplasia. Presence of peptic ulcer disease. History of gastrointestinal bleeding or endoscopic stigmata of recent bleeding Severe dyspeptic symptoms Advanced Chronic Kidney Disease Moderate to severe hepatic impairment Pregnancy, intention to become pregnant, or breastfeeding. Concomitant Use of Rilpivirine, Digoxin, Methotrexate, Diuretics K21 Gastro-esophageal reflux disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group one: Erosive Esophagitis (EE), Vonoprazan Arm, Participants will receive vonoprazan (phorize, Abidi) 20 milligrams tablets once daily for 8 weeks as initial treatment, followed by vonoprazan 10 miligrams tablets once daily for 16 weeks as maintenance treatment. Intervention group two: Erosive Esophagitis (EE), Pantoprazole Arm, Participants will receive pantoprazole (Pentomid, Tehran Shimi) 40 milligrams once daily, taken before breakfast, followed by Pentomid 20 milligrams before breakfast for 16 weeks. Intervention Group three: Non-Erosive Reflux Disease (NERD), Vonoprazan Arm, Participants will receive vonoprazan (phorize, Abidi) 10 milligrams tablets once daily for 8 weeks. Intervention Group four: Non-Erosive Reflux Disease (NERD), Pantoprazole Arm, Participants will receive pantoprazole (Pentomid, Tehran Shimi) 20 milligram tablets once daily, taken before breakfast for 8 weeks. Total heartburn-free time (Daytime). Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting the treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting the treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: Single designed form (By study researchers) for recording daytime and nighttime symptoms and the use of rescue medications for symptom control. Total heartburn-free time (night time). Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: Single designed form (By study researchers) for recording daytime and nighttime symptoms and the use of rescue medications for symptom control. Total Heartburn free days. Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: Single designed form (By study researchers) for recording daytime and nighttime symptoms and the use of rescue medications for symptom control. Percentage of Heartburn-free individuals at the end of the study. Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: Single designed form (By study researchers) for recording daytime and nighttime symptoms and the use of rescue medications for symptom control. The GERD-Q (Gastroesophageal Reflux Disease Questionnaire) Score. Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: the GERD-Q (Gastroesophageal Reflux Disease Questionnaire). Score of GSAS : GERD Symptom Assessment Scale. Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: GSAS : GERD Symptom Assessment Scale Queestionnaire. Adverse effects. Timepoint: The time of intervention is considered as week 0. Non-erosive reflux arm: right before starting treatment (week 0), week 4 and week 8, Erosive esophagitis arm: right before starting treatment (week 0), week 4, week 8, week 12, week 16, week 20, week 24. Method of measurement: pre-designed forms of adverse effects. Iran University of Medical Sciences Abidi Pharmaceutical company Iran University of Medical Sciences Approved 2025-11-15 Ethics committe of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran Tehran Iran (Islamic Republic of)