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).
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitisHealth Condition 2: null- Gastroesophageal Reflux Disease
- Registration Number
- CTRI/2009/091/001053
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, BelchingTimepoint: Day 0, Week 1, Week 2 and Week 4
- Secondary Outcome Measures
Name Time Method SafetyTimepoint: Day 0, Week 1, Week 2 and Week 4