A clinical Trial in Patients with Symptomatic Gastroesophageal Reflux Disease (GERD). Clinical trial is to study efficacy, safety and tolerability of Ilaprazole 10 mg Tablet in comparison to Omeprazole 20 mg Tablet(reference product).

A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ilaprazole 10 mg Tablet Vs Omeprazole 20 mg Tablet in patients with Symptomatic Gastroesophageal Reflux Disease (GERD).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001053

Enrollment

200

Registered

2009-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis Health Condition 2: null- Gastroesophageal Reflux Disease

Interventions

Intervention1: Ilaprazole 10 mg Tablet: once daily for a period of 4 weeks Control Intervention1: Omeprazole 20 mg Tablet: once daily for a period of 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and non-pregnant females (with negative β-human chorionic gonadotrpin test). Female patients on adequate contraceptive control. 2. Patients with diagnosis of symptomatic GERD, ie. History of atleast 2 episodes of heartburn per week that partially responded to treatment with a proton-pump inhibitor (PPI), 3. H2 receptor antagonist (H2RA) or antacids within the 30 days prior to screening. 4. Patient willing to comply with study procedures and requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnant and nursing women. 2. History of previous esophageal or gastric surgery. 3. History of bleeding tendencies, cirrhosis and esophageal varices. 4. History of hypersensitivity or allergy to Omeprazole or Ilaprazole. 5. Patients who would require concomitant therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates (>165 mg/day), quinidine, warfarin, diazepam, diphenylhydantoins, mephenytoin, H2-receptor antagonists, anticholinergics or prostaglandin analogues. 6. Alcoholics, smokers, tobacco addicts. 7. Immunocompromised states and patients with systemic infections. 8. Patients with severe cardiac, hepatic, renal, or cerebrovascular diseae, malignancy, chronic uncontrolled systemic disease e.g., diabetes, hypertension, asthma, collagen disorders, etc. or any other serious medical illness. 9. Patients who have participated in a new drug study in the past 3 months. 10. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.

Design outcomes

Primary

Measure	Time frame
Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, BelchingTimepoint: Day 0, Week 1, Week 2 and Week 4	—

Secondary

Measure	Time frame
SafetyTimepoint: Day 0, Week 1, Week 2 and Week 4	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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