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

NCT02922699 | Completed Phase 4

• 1 other identifier: DRL _ RUS / PMS / 201 2 / OMEZ
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• H Pylori eradicaion rates

  Baseline to 6 weeks

Study Arms (2)

Omeprazole 40mg

EXPERIMENTAL

Omez 40mg OD

Drug: OMEZ 40

Omeprazole 80 mg

ACTIVE COMPARATOR

Omez 80mg OD

Drug: OMEZ 80

Interventions

OMEZ 40 DRUG

Omez 40 given to patients for 58days along with Amoxicilin and Clarithromycin

Also known as: OMEPRAZOLE 40MG

Omeprazole 40mg

OMEZ 80 DRUG

Omez 80 patients for 58days along with Amoxicilin and Clarithromycin

Also known as: OMEPRAZOLE 80 MG

Omeprazole 80 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• V.D Pasechnikov, MD

  Stavropol State Medical University1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 4, 2016
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 4, 2016

Record last verified: 2016-10