A clinical trial to study the efficacy and safety of fixed dose combination in the treatment of gastroesophageal reflux disease.
- Conditions
- Health Condition 1: null- GASTROESOPHAGEAL REFLUX DISEASE (GERD)
- Registration Number
- CTRI/2012/04/002575
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
1.Male or female patients aged between 18-70 years.
2.Patients with GERD (Gastro esophageal Reflux Disease).
3.Patients willing to give informed consent.
1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with peptic ulcer or Zollinger-Ellison syndrome.
3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinsonâ??s disease, epilepsy, mania and inflammatory bowel disease.
5.Patients with any severe illnesses (hepatic, renal, cardiac).
6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
7.History of heavy smoking ( > 20 cigarettes per day).
8.Hypersensitive to either Pantoprazole or levosulpiride.
9.Recent (in the past two years) drug dependence or abuse.
10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method