Efficacy and Saafety of Omez Iin Patients With H.Pylori Associated Diseases

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of efficacy of H.pylori eradication during first line therapy using standard or high doses of omeprazole administered twice daily in combination with amoxicillin and clarithromycin for 10 days.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Clarithromycin; Omeprazole

Criteria

Inclusion Criteria:

• Patients of both sexes between the ages of 18 and 75 years old, ready to sign informed consent and and agree to follow all requirements of study protocol.

• The patient should be prepared to fill out questionnaires on their own wedge and symptoms.

• Non pregnant, not nursing patient.

• Patients must be either n of stklimaktericheskom period, or surgically sterile, or throughout the study period using contraceptive methods, the reliability of more than 90%. - Contraceptive methods with the reliability of more than 90% of the normal used e of include the cervical cap with spermicide, diaphragm with spermicide, condoms, oral contraceptives, intrauterine devices, acetate HCWs to siprogesterona and levonorgestrel subdermal implants;

Exclusion Criteria:

• A history of surgery performed to reduce gastric acid secretion in the stomach or esophagus to operations and / or upper digestive tract.

• The presence of obstructive strictures or esophageal ulcers, varicose veins vehi ie water, esophageal achalasia.

• Barrett's esophagus.

• patients taking other medications for GERD over a period of two weeks or PPIs during the preceding and a following of the month.

• Zollinger-Ellison syndrome .

• Peptic ulcer and 12 duodenal ulcer in acute

• erosive gastro.

• Cancer of the stomach or esophagus.

• Coronary heart disease.

• Colic disease.

• Chronic pancreatitis.

• Gallstone disease.

• Pyloric stenosis.

• Regular intake of steroids or any other drugs ulcerogenic, n as an example of NSAIDs.

• Pregnancy, Kor m tion feeding.

• Patients with esophagitis endoscopically established 4 th or higher degree in s reflection (on a modified scale Hetzel-Dent ) .

• Impaired function of average weight of the liver.

• hypersensitivity to the drug: omeprazole and domperidone