Clinical trial: A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg (NCT00464308)

Eligibility criteria:
Inclusion Criteria:

          -  Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or
             lower part of the chest up towards the neck) with or without regurgitation

          -  Patients must have had episodes of heartburn with or without regurgitation for 3
             months or longer, and for >= 3 days in the 7 days prior to randomisation

          -  Able to understand and complete questionnaires, able to give written informed consent,
             and have access to a telephone

        Exclusion Criteria:

          -  Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal
             symptoms that, in the opinion of the investigator, require further investigation prior
             to or coincident with initiation of PPI therapy which would include, but are not
             limited to, alarm symptoms such as unintentional weight loss, progressive difficulty
             swallowing (dysphagia), iron deficiency anaemia and epigastric mass

          -  Significant gastrointestinal obstruction, major gastric or oesophageal surgery
             (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric
             stenosis, extra-oesophageal manifestations of reflux disease

          -  Patients with Barrett's oesophagus (>3cm), Zollinger-Ellison Syndrome, scleroderma,
             malignancy (other than non-melanoma skin cancers) present within the last 5 years,
             hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant
             condition that, in the opinion of the investigator, could interfere with the patients
             participation or compliance in the study such as past or current history of alcohol or
             drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have
             participated in an investigational drug or investigational device study within 30 days
             prior to the baseline visit or who are expected to do so during the 4 week study
             period

          -  Female patients who are currently pregnant or breast feeding, or who, in the opinion
             of the investigator, may become pregnant throughout the study

          -  Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation,
             anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump
             inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or
             bismuth compounds within 14 days of randomisation
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? Entailment