Clinical trial: Open, Randomised, Multi-center Study of on Demand Versus Continuous Esomeprazole Treatment in Patient With GERD (NCT02670642)

Eligibility criteria:
Inclusion Criteria:

          -  Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as
             a burning feeling, rising from the stomach or lower part of the chest up towards the
             neck), for longer than 6 months.

          -  Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or,
             if PPI treatment has been started within the last 7 days prior to endoscopy, then
             heartburn occurring for 4 days or more during the last 7 days prior to start of PPI
             treatment

          -  Male or female, at least 18 years of age (for Austria, at least 19 years of age)

          -  Have given written informed consent

          -  Ability to read and write (literate)

          -  7 symptom free (from heartburn) days in the last week prior to randomisation (day of
             visit not included)

        Exclusion Criteria:

          -  Documented esophageal mucosal break

          -  History of esophageal, gastric or duodenal surgery, except closure and oversewing of
             an ulcer

          -  Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel
             disturbance and/or bloating, that in the opinion of the investigator is likely to be
             due to irritable bowel syndrome or two or more of the following criteria:

               -  Symptoms relieved by defecation

               -  Symptoms associated with change in frequency of stools

               -  Symptoms associated with change in form of stools

          -  Any significant "alarm symptoms" such as unintentional weight loss, haematemesis
             melaena, jaundice or any other sign indicating serious or malignant disease.

          -  Subjects with current or historical evidence of the following diseases/conditions

               -  Zollinger Ellison syndrome

               -  Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal
                  spasm

               -  Complications of GERD such as esophageal stricture, ulcer and/or macroscopic
                  Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic
                  changes in the esophagus

               -  Evidence of upper gastrointestinal malignancy at the screening endoscopy

               -  Gastric and/or duodenal ulcers within the last 2 years

               -  Malabsorption

               -  Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver
                  disease as judged by the investigator

               -  Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or
                  insulin is acceptable

               -  Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or
                  embolus

          -  Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy

          -  Use of PPIs for more than 5 days in the last 7 days prior to endoscopy

          -  Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment
             of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the
             endoscopy and visit 1 and throughout the study

          -  Need for continuous concurrent therapy with

               -  NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily
                  for cardiovascular prophylaxis)

               -  anticholinergics

               -  prostaglandin analogues

               -  phenytoin

               -  ketoconazole

               -  itraconazole

               -  warfarin and other vitamin K antagonists

          -  Pregnancy or lactation. Women of childbearing potential must maintain effective
             contraception during the study period as judged by the investigator (for Austria:
             Women of child-bearing potential may only be included when their pregnancy status is
             assessed by the investigator prior to entry and then at monthly basis. For
             South-Africa and Spain:

        Women of child-bearing potential may only be included when their pregnancy status is
        assessed by the investigator prior to endoscopy)

          -  Use of any other investigational compound 28 days prior to start and during the study

          -  Requirement of an interpreter (illiterate)

          -  Alcohol and/or drug abuse or any condition associated with poor compliance, including
             expected non-co-operation, as judged by the investigator

          -  Previous participation in this study

          -  Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and
             any other constituents of the formulation. Known hypersensitivity to substituted
             benzimidazole
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.


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