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Real World Data will be collected using Electronic Medical Record to see the effect of Omeprazole and Pantoprazole in relieving symptoms of acidity and stomach complains

A Real World Evidence (RWE) Study to Evaluate the Effectiveness of Proton Pump Inhibitors (PPIs) Omeprazole and Pantoprazole for Symptomatic Relief of Gastro-Esophageal Reflux Disease (GERD)/ Acid Peptic Disease (APD) - GERD EMR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/051166
Enrollment
600
Registered
2023-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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 Health Condition 2: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

None listed

Sponsors

Dr. Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged >=18 years of either gender Patients being newly treated for GERD/APD [treatment naïve patients defined as those patients who have not received (prescribed or self-administered) any anti-acidity or anti-ulcer agent since the last two weeks] Treatment duration of at least 4 weeks with study medication Availability of patient information in Electronic Medical Record (EMR)

Exclusion criteria

Exclusion criteria: Combinatorial treatment with Proton Pump Inhibitors (PPIs) and prokinetics or antacids within 2 weeks preceding study enrolment Prior treatment with Histamine 2 Receptor Antagonists (H2RAs) within 2 weeks preceding study enrolment Prior treatment with antacids within 2 weeks preceding study enrolment Ongoing treatment with any PPI Refractory GERD already treated with PPI for 6-12 weeks Any condition that, in opinion of the physician, is refractory to treatment with study medications Any condition that, in opinion of the physician, does not justify use of patient-related information in the study

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of omeprazole and pantoprazole based on satisfactory resolution of GERD/APD symptoms in adult patients in IndiaTimepoint: Baseline, Week 2 and Week 4—

Secondary

MeasureTime frame
To assess safety and tolerability To identify patient profile of APD â?¢ To identify patients with comorbid conditions like hypertension, diabetes mellitus, cardiac conditions, obesity, etc. â?¢ To assess the response of patients on medications for hypertension, diabetes mellitus, cardiac conditions, etc To identify smokers and/or chronic alcohol users amongst GERD/APD patientsTimepoint: 2 weeks and 4 weeks—

Countries

India

Contacts

Public ContactDr Monjori Mitra

Medclin Research Pvt Ltd

monjori.mitra@medclinsearch.com9831075734

Outcome results

None listed

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