CTRI/2022/01/039744
Not yet recruiting
Phase 4
A prospective, randomized, double-blind, two-arm,active-controlled, parallel, multicentre, post marketingclinical trial to assess the efficacy and safety ofRabeprazole Sodium EC Capsules 20mg as comparedto conventional Rabeprazole Gastro Resistant Tablets IP20mg in patients with gastro-oesophageal reflux disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zydus Healthcare Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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