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).

Phase 3

Completed

• Conditions: Gastro-esophageal reflux disease with esophagitis, Gastroesophageal Reflux Disease ,

• Registration Number: CTRI/2009/091/001053
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is 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 (Reference Drug), for 4 weeks in 200 patients with Symptomatic Gastroesophageal Reflux Disease. The study will start on 15th January 2010.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Efficacy will be measured by assessing change from baseline to week 1, 2 and 4 symptom and sign scores of heartburn, acid regurgitation, epigastric pain/ bloating, and belching.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-15
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Males and non-pregnant females (with negative β-human chorionic gonadotrpin test).
• Female patients on adequate contraceptive control.
• 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.
• Patient willing to comply with study procedures and requirements.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, Belching	Day 0, Week 1, Week 2 and Week 4

Secondary Outcome Measures

Name	Time	Method
Safety	Day 0, Week 1, Week 2 and Week 4

Trial Locations

Locations (3)

A V M College; 🇮🇳 Pondicherry, PONDICHERRY, India

CSI Kalyani General Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Sri Dilip Clinic; 🇮🇳 Bangalore, KARNATAKA, India

A V M College

🇮🇳Pondicherry, PONDICHERRY, India

Dr Mrs S Vithiavathi

Principal investigator

0994557798

drsln@sify.com