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

NCT02140073 | Unknown Phase 4

• 1 other identifier: OM2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

GERD

Keywords

GERD; Omez; Omez DSR; heartburn; esophagitis; omeprazole; omeprazole+domperidone

Outcome Measures

Primary Outcomes (2)

• change incidence of heartburn after 8 weeks of treatment with Omez-DSR preparation in comparison with OMEZ preparation

  questionnaire

  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

  questionnaire

  change from baseline severity of heartburn at 8 weeks

Secondary Outcomes (3)

• proportion of patients with completely jugulated heartburn

  4 and 8 weeks of treatment

• number of days without heartburn

  4 weeks of treatment

• proportion of patients with resolved esophagitis

  after 8 weeks of treatment

Other Outcomes (3)

• incidence of adverse events in the group of patients who received at least one dose of the medicinal product after randomization

  8 weeks of treatment

• incidence of serious adverse events

  8 weeks of treatment

• incidence of severe adverse events

  8 weeks of treatment

Study Arms (2)

omeprazole+domperidone SR

EXPERIMENTAL

patients with GERD receive omeprazole 20mg + domperidone SR 30mg , 2 capsules in the morning

Drug: omeprazole

omeprazole

ACTIVE COMPARATOR

omeprazole 40mg in the morning

Drug: omeprazole+domperidone SR

Interventions

omeprazole+domperidone SR DRUG

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

Also known as: Omez DSR

omeprazole

omeprazole DRUG

40mg in the morning

Also known as: Omez

omeprazole+domperidone SR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Belarusian Medical Academy of Post-Graduate Education: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (2)

Gastroenterology and Nutrition Department. Byelorussian Medical Academy Postgraduate Education

Minsk, 220013, Belarus

Location

Mother and Child National Reaserch Centre

Minsk, 220053, Belarus

Location

Related Publications (1)

• Marakhouski KY, Karaseva GA, Ulasivich DN, Marakhouski YK. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease. Clin Med Insights Gastroenterol. 2017 May 31;10:1179552217709456. doi: 10.1177/1179552217709456. eCollection 2017.

  PMID: 28607547 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Esophagitis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yury Kh Marakhouski, Professor of Clinical Medicine

  Belarusian Medical Academy of Post-Graduate Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: May 16, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 16, 2014

Record last verified: 2014-03

Locations

BE (2)