Clinical trial: Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity (NCT02140073)

Eligibility 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;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction