Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Fixed Dose Combination of Esomeprazole 40mg and Levosulpiride SR 75 mg capsule: Once daily for 4 weeks
Route oral
Control Intervention1: NA: NA
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be considered for enrollment in the study: 1.Male or female patients aged between 18-65 years. 2.Patients with known history of Gastro esophageal reflux disease (GERD) within last 03 months. 3.Patients who are on Proton pump inhibitor (PPI) alone since 4 weeks prior to screening and not adequately controlled. •Minimum dose/day: Pantoprazole (40 mg), Esomeprazole (20 mg), Omeprazole (20 mg). Rabeprazole (20mg) and Lansoprazole (15 mg). 4.Patients willing to give informed consent.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria must be excluded from enrollment in the study: 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.Heavy smokers ( > 10 cigarettes per day in last 06 months). 8.History of hypersensitivity or known contraindication 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with adverse events and serious adverse events Timepoint: Baseline, Day: 14, Day:28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Frequency Scale for the Symptoms of GERD Scale (FSSG) from baseline. Change in Severity of symptoms of GERD by Likert Scale from baseline Clinical Global Impression of Improvement (CGI-I) Clinical Global Impression of Severity (CGI-S) Evaluation of neurological side effects by Modified Simpson Angus Scale Timepoint: Time frame:02 and 04 weeks Time frame: 02 and 04 weeks Time frame: 02 and 04 weeks Time frame: Day-0 and 04 weeks Time frame: Day-0 and 04 weeks | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma laboratories Limited
Outcome results
None listed