An Interventional Study of Rabeprazole Treatment in 286 Patients with Acid Reflux Disease Not Controlled by Standard PPI treatment

A randomized, double blind, double dummy, active controlled, parallel-group, multicenter, phase III study to compare the efficacy and safety of rabeprazole sodium 40 mg MR capsule once daily of Dr. Reddys Laboratories Limited with rabeprazole sodium 20 mg Enteric coated Tablet once daily in patients with erosive gastroesophageal reflux disease, refractory to standard PPI therapy - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106095

Enrollment

286

Registered

2026-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Rabeprazole Sodium MR capsule 40 mg: Patient in test arm will receive rabeprazole 40 mg MR capsules and matching placebo Rabeprazole 20 mg enteric coated tablet OD for upto 8 weeks Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1 Males and females aged between 18 and 65 years both inclusive 2 Subject diagnosed with endoscopically confirmed erosive GERD and experiencing GERD symptoms heartburn or regurgitation on more than 4 days per week for at least 4 weeks prior to screening visit. Los Angeles (LA) Classification System for erosive Esophagitis to be used 3 Subjects on once daily Proton Pump Inhibitors for at least 8 weeks prior to screening 4 Subjects without any organic GI tract pathology based on upper GI endoscopy 5 Subjects willing to provide written informed consent and willing to comply with study instructions for its duration 6 Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). OR Postmenopausal for at least 1 year

Exclusion criteria

Exclusion criteria: 1History of hypersensitivity or allergy to any of the study drugs or it components 2.subjects with presence of alarming symptoms for probable malignancy( eg weight loss greater than 5% in the last 60 days persistent vomiting progressive dysphagia orodynophagia

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric coated tablet in patients with erosive Gastroesophageal Reflux Disease, Symptomatic despite receiving standard once daily PPI for at least 8 weeks prior to randomizationTimepoint: 4 weeks , 8 weeks	—

Secondary

Measure	Time frame
To evaluate the safety and efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric Coated tablet in patients with erosive Gastroesophageal Reflux Disease, Symptomatic despite receiving standard once daily PPI for at least 8 weeks prior to randomizationTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactMr Swarup Wani

Dr Reddys Laboratories Ltd

acgangaram@drreddys.com9740694650

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026