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A Observational Study to understand the Tolerability and Efficacy of Vonoprazan in Patients with Reflux Esophagitis.

Vonoprazan In Real world evidence for Tolerability and efficacy in symptomatic management of reflUx Esophagitis. - VIRTUE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/105353
Enrollment
1800
Registered
2026-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Mankind Pharma Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Medical records of adult patients equal or above 18 years of age with symptoms of reflux esophagitis and treated with vonoprazan 20 mg once daily as per local prescribing guidelines will be retrieved and screened for further analysis.

Exclusion criteria

Exclusion criteria: Screened records will not be considered for evaluation if patients had esophageal comorbidities, prior gastrointestinal or esophageal surgery, recent use of acid-suppressing therapy, H. pylori eradication within 28 days, significant hepatic dysfunction, inflammatory bowel disease, malignancy, or hypersensitivity to vonoprazan.

Design outcomes

Primary

MeasureTime frame
Effectiveness will be evaluated as treatment response based on mean improvement in the FSSG questionnaire score and heart burn resolutionTimepoint: From baseline till 2 weeks and 4 weeks after treatment initiation

Secondary

MeasureTime frame
Physician Global Assessment (PhGA) Scale for treatment response, as well as safety and tolerability evaluated through recorded adverse drug reactions.Timepoint: From baseline till 2 weeks and 4 weeks after treatment initiation

Countries

India

Contacts

Public ContactDr Darshan Rana MBBS MD

Mankind Pharma Ltd

darshan.rana@mankindpharma.com9766016028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026