A prospective,randomized,double-blind,2-arm,active-controlled,parallel,multicentre,postmarketingclinical trial to assesstheefficacy andsafety ofRabeprazole SodiumEC Capsules20mg ascomparedtoconventionalRabeprazoleGastroResistantTablets IP20mg in patients with gastro-oesophageal reflux disease

Phase 4

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

• Registration Number: CTRI/2022/01/039744
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and Female patients of age 18-60 years (both inclusive).

2. Patients with established diagnosis of GERD with symptoms of heart burn

3. Patients having moderate to severe heart burn symptoms on at least two occasions during the last 7 days

4. Patients should not have taken any PPI / H2 receptor blocker in last one week.

5. Patients willing to give written informed consent and comply with the study procedure

6. Patient literate enough to fill the diary card

Exclusion Criteria

1. Patient is a refractory case of GERD i.e. patient has tried Rabeprazole 20mg /

Pantoprazole 40mg or equivalent for 4 weeks without any response in past

2. Pregnant or Lactating females; or female patients of childbearing potential unwilling to

use effective contraception

3. Current or past history of:

o Increased gastrointestinal motility e.g. in patients with gastrointestinal

hemorrhage, mechanical obstruction or perforation

o Atrophic gastritis or gastric malignancy or other GI malignancy

o Acute peptic ulcer and/or ulcer complications or history of active gastric or

duodenal Ulcers within 4 weeks prior screening

o Patients with Zollinger-Ellision syndrome or other hypersecretory condition

o GERD complications like Endoscopic Barretts oesophagus and/or definite

dysplastic changes in the oesophagus

o Pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal

o Gastroesophageal surgery and planned surgery during the study duration

o Bleeding disorder or History of hematemesis within last 2 months

4. Subjects with any other clinically significant uncontrolled systemic diseases such as

gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine,

immunological or hematological disorders or malignancy

5. Subjects with continuing history of alcohol and/or drug abuse

6. Subjects with history of allergy to Rabeprazole or any other proton pump inhibitor

7. Participation in another clinical trial in the past 3 months prior to screening

8. Any other reason for which the investigator feels that patient should not participate

Study & Design

• Study Type: PMS
• Study Design: Not specified