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

NCT02140073 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-16

No results posted yet for this study

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

Conditions

  • GERD

Interventions

DRUG

omeprazole+domperidone SR

omeprazole 20mg+domperidone SR 30mg, 2 capsules in the morning

DRUG

omeprazole

40mg in the morning

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    collaborator INDUSTRY

  • Belarusian Medical Academy of Post-Graduate Education

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Belarus

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140073 on ClinicalTrials.gov