Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: FDC of Esomeprazole 40 mg DR
and Levosulpiride 75 mg ER capsule: FDC of Esomeprazole 40 mg DR
and Levosulpiride 75 mg ER capsule will given O.D. for 28 days
Control Intervention1: NIL:
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Male or female GERD patient with age of 18 years or above (18 years should be completed) -Patients who do not respond to PPI alone and need addition of prokinetic agent to current PPI therapy and can be switched to FDC based on investigator discretion. Patient must have taken any of the following PPIs for at least 2 weeks before screening with inadequate response.) • Lansoprazole 30 mg/day, • Pantoprazole 40 mg/day, • Omeprazole 40 mg/day and • Rabeprazole 20 mg/day. -Patient with prolactin and liver function level (AST,ALT, Bilirubin [total, direct, indirect] and Alkaline phosphatase) within normal limits. -Patients who are willing to give informed consent. -Patients who are willing to adhere to protocol requirements.
Exclusion criteria
Exclusion criteria: -History of Barrettâ??s esophagus or dysplastic changes esophagus. -History of acute peptic ulcer and/or ulcer complications. - History of any malignant disease in any system or organ. - Patients with a history of gastric hypersecretory condition eg. Zollinger-Ellison syndrome -Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic, gastrointestinal (other than GERD) or endocrine disorder that may impact outcome of study based on investigator discretion. - Any major surgery in previous 1 month or history of upper GIT surgery - History of alcohol or drug abuse - Use of any investigational drug and/or device or participation in another clinical study within 1 month before screening. - Any psychiatric or mental disease compromising the ability to give the consent for participation in the study. -Hypersensitivity to PPI or levosulpiride - Patient with clinical significant laboratory examination. (Refer inclusion criteria for Liver function test & Prolactin level) - Women with positive urine pregnancy test. -Women who are breast-feeding or females of childbearing potential who are not using acceptable contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of nature and incidence of treatment emergent adverse events (AEs). Change in vital signs and laboratory Safety Parameters (specially liver function test (ALT, AST, Bilirubin [total, direct, indirect], alkaline phosphatase level) and prolactin levels) from baseline to end of treatment period. Timepoint: Day 7 AND dAY 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean improvement in FSSG (frequency scale for the symptoms of gastroesophageal reflux disease (GERD) score from baseline to end of the treatment visit.Timepoint: Day 7 AND DAY 28 | — |
Countries
India
Contacts
Public ContactDr Sushil Kumar Anand
Torrent Pharmaceuticals Ltd
Outcome results
None listed