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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251101067844N1

Enrollment

730

Registered

2026-01-13

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal Reflux Disease. Gastro-esophageal reflux disease

Interventions

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 treatmen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Agah

Iran University of Medical Sciences

shahram.agah@isge.ir+98 21 6435 2358

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026