Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of omeprazole in combination with domperidone in GERD treatment for subsequent efficient pharmacotherapy of GERD.

Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To assess the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare the efficacy of omeprazole in combination with domperidone regarding change of incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the efficiency and advantages of one GERD therapy considering efficacy, safety, and individual variance of patients' reactions

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

Details

• Lead Sponsor: Belarusian Medical Academy of Post-Graduate Education
• Collaborator: Dr. Reddy's Laboratories Limited
• Treatments: Domperidone; Omeprazole

Criteria

Criteria of inclusion of subjects

• desire to participate in the trial and ability to sign the informed consent;

• age above 18;

• gastroesophageal reflux disease, manifested in heartburn no less than twice a week prior to the 1st visit;

• use for the trial period of safe contraception methods for women of fertile age;

• results of ultrasonography (US) of abdominal cavity organs (ACO) performed in the last 6 months before the enrollment.

Criteria of non-inclusion refusal to undergo the endoscopic examination;

• gastroesophageal reflux disease with severe esophagitis (grade С or D against the Los Angeles classification);

• Barrett esophagus;

• pregnancy or lactation;

• administration of nonsteroidal antiinflammatory drugs (NSAIDs), aspirin, bisphosphonates, nitrates, calcium antagonists, proton pump inhibitors or Н2-blockers, prokinetics, clopidogrel;

• participation in other clinical trial;

• history of allergic reaction or intolerance of components of medicinal products;

• esophageal stricture;

• gastrectomy or gastric resection;

• malignant neoplasms in any location at present;

• alcohol abuse;

• severe cardiovascular or respiratory insufficiency;

• hepatic insufficiency;

• renal insufficiency.

Criteria of exclusion

• investigator's opinion on the necessity to exclude the patient for their own benefit;

• erroneous enrollment;

• investigator's decision to exclude the patient due to serious deviation from the trial program;

• serious adverse events (SAEs) including death (stating the date of death);

• adverse events (AEs) requiring monitoring and drug therapy;

• acute diseases or conditions which in the investigator's opinion require the patient to be excluded from the trial;

• administration during the trial of NSAIDs, aspirin, bisphosphonates, nitrates, calcium antagonists, proton pump inhibitors or Н2-blockers, prokinetics, antacids (except for the tested MP or the comparator MP) or the necessity for such treatment to be prescribed;

• positive pregnancy test (for women);

• patient's failure to appear for the visit;

• patient's refusal to continue the trial;

• intolerance of the tested MP or the comparator MP;