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

NCT02140073 Phase 4 UNKNOWN

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

Details

Lead sponsor	Belarusian Medical Academy of Post-Graduate Education
Phase	Phase 4
Status	UNKNOWN
Enrolment	60
Start date	2013-12
Completion	2014-06

Conditions

• GERD

Interventions

• omeprazole+domperidone SR
• omeprazole

Primary outcomes

• change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation — change from baseline incidence of heartburn after 8 weeks of treatment
  questionnaire
• change severity of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation — change from baseline severity of heartburn at 8 weeks
  questionnaire

Countries

Belarus