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A study to evaluate the Efficacy and safety of Vonoprazan in the management of Gastro Esophageal Reflux Disease in a tertiary care hospital

Efficacy and safety of Vonoprazan Versus Pantoprazole in the management of Gastro Esophageal Reflux Disease in a tertiary care hospital,Chengalpattu-A single blind randomised controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081537
Enrollment
90
Registered
2025-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention1: Vonaprazan: Vonaprazan 20mg once daily for 28 days Control Intervention1: Pantoprazole: Pantoprazole 40mg once daily for 28 days

Sponsors

Dr Shaki S
Lead Sponsor
DRSHAKI S
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients having GERD symptoms like heart burn, regurgitation, epigastric pain,bloating, dysphagia, nausea for more than 3 weeks 2. Patients willing to participate and given written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant / Lactating mother 2. Patient with malignancy, history of abdominal surgeries, any major hematologic, hepatic, metabolic gastrointestinal or endocrine disorders requiring any other anti GERD medications 3. Patients with impaired liver and renal function 4. Patients with abnormal laboratory tests at baseline (including liver enzymes greater than twice the upper limit of normal), 5. Patients refractory to a 2-month course of H2-blocker or PPI therapy for GERD treatment, 6. Patients who took PPI within 14 d of screening or a H2-blocker or prokinetic agent within 7 d of screening, 7. Oral steroids, aspirin or who were unable to discontinue the use of anticholinergics, cholinergics, spasmolytics, opiates or sucralfate 8. Patients with poorly controlled associated disease (such as heart disease, coagulation disorders, thyroid disorders) were also excluded from the study 9. Patients who required daily use of non-steroidal anti-inflammatory drugs (NSAIDs),

Design outcomes

Primary

MeasureTime frame
To assess the improvement in GERD symptomsTimepoint: 28 days

Secondary

MeasureTime frame
GI endoscopy changesTimepoint: 28days

Countries

India

Contacts

Public ContactDR SHAKI S

Karpaga vinayaga institute of medical sciences and research centre

sunilpharmac@gmail.com8973463297

Outcome results

None listed

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