Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140073
Recruitment Status : Unknown
Verified March 2014 by Belarusian Medical Academy of Post-Graduate Education.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Dr. Reddy's Laboratories Limited
Information provided by (Responsible Party):
Belarusian Medical Academy of Post-Graduate Education

Brief 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


Condition or disease Intervention/treatment Phase
GERD Drug: omeprazole+domperidone SR Drug: omeprazole Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
Study Start Date : December 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: omeprazole+domperidone SR
patients with GERD receive omeprazole 20mg + domperidone SR 30mg , 2 capsules in the morning
Drug: omeprazole
40mg in the morning
Other Name: Omez

Active Comparator: omeprazole
omeprazole 40mg in the morning
Drug: omeprazole+domperidone SR
omeprazole 20mg+domperidone SR 30mg, 2 capsules in the morning
Other Name: Omez DSR




Primary Outcome Measures :
  1. 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 ]
    questionnaire

  2. 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 ]
    questionnaire


Secondary Outcome Measures :
  1. proportion of patients with completely jugulated heartburn [ Time Frame: 4 and 8 weeks of treatment ]
    number of patients with completely jugulated heartburn after 4 weeks of treatment and 8 weeks of treatment

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

  3. proportion of patients with resolved esophagitis [ Time Frame: after 8 weeks of treatment ]
    based on Esophagogastroduodenoscopy in subjects with esophagitis at the time of enrollment


Other Outcome Measures:
  1. incidence of adverse events in the group of patients who received at least one dose of the medicinal product after randomization [ Time Frame: 8 weeks of treatment ]
    questionnaire

  2. incidence of serious adverse events [ Time Frame: 8 weeks of treatment ]
    questionnaire

  3. incidence of severe adverse events [ Time Frame: 8 weeks of treatment ]
    questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140073


Locations
Layout table for location information
Belarus
Gastroenterology and Nutrition Department. Byelorussian Medical Academy Postgraduate Education
Minsk, Belarus, 220013
Mother and Child National Reaserch Centre
Minsk, Belarus, 220053
Sponsors and Collaborators
Belarusian Medical Academy of Post-Graduate Education
Dr. Reddy's Laboratories Limited
Investigators
Layout table for investigator information
Principal Investigator: Yury Kh Marakhouski, Professor of Clinical Medicine Belarusian Medical Academy of Post-Graduate Education

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Belarusian Medical Academy of Post-Graduate Education
ClinicalTrials.gov Identifier: NCT02140073     History of Changes
Other Study ID Numbers: OM2013
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: March 2014
Keywords provided by Belarusian Medical Academy of Post-Graduate Education:
GERD
Omez
Omez DSR
heartburn
esophagitis
omeprazole
omeprazole+domperidone
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Domperidone
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents