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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02140073
• Date of registration: 24/03/2014
• Prospective Registration: No
• Primary sponsor: Belarusian Medical Academy of Post-Graduate Education
• Public title: Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
• Scientific title: Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
• Date of first enrolment: December 2013
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT02140073
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belarus

Contacts

• Name: Yury Kh Marakhouski, Professor of Clinical Medicine
• Affiliation: Belarusian Medical Academy of Post-Graduate Education

Key inclusion & exclusion 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 ? 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
?2-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 ?2-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;



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

GERD

Intervention(s)

Drug: omeprazole+domperidone SR

Drug: omeprazole

Primary Outcome(s)

change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation [Time Frame: change from baseline incidence of heartburn after 8 weeks of treatment]

change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation [Time Frame: change from baseline severity of heartburn at 8 weeks]

Secondary Outcome(s)

proportion of patients with completely jugulated heartburn [Time Frame: 4 and 8 weeks of treatment]

proportion of patients with resolved esophagitis [Time Frame: after 8 weeks of treatment]

number of days without heartburn [Time Frame: 4 weeks of treatment]

Secondary ID(s)

OM2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dr. Reddy's Laboratories Limited