Clinical trial: Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms. (NCT00553449)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have had a minimum three-month history of symptomatic GERD, with
             heartburn as the predominant symptom, and must report nocturnal heartburn symptoms
             (i.e., heartburn symptoms experienced during the night-time period, between 2200 and
             0600h)

          -  Patients must currently be taking a proton-pump inhibitor (PPI) or histamine-2
             receptor antagonist (H2RA) at least four weeks prior to study admission

          -  Patients must be able to read, write and understand the language of the HRQOL and
             productivity assessment instruments (PAGI-SYM, PAGI-QOL, WPAI-GH) i.e., English or
             French

          -  Patients must have been at least 80% compliant with their current acid suppressive
             therapy, and must have completed a minimum of 11 of 14 nocturnal heartburn ratings
             during the run-in period (i.e. <=3 "missing" nocturnal heartburn ratings during the
             14-day period)

          -  Patients must have a total nocturnal heartburn symptom score of >4 points during the
             2-week run-in period

          -  3 "missing" nocturnal heartburn ratings during the 14-day period) as recorded in the
             diary

          -  Night-time heartburn control assessment of "very dissatisfied, dissatisfied, neither
             dissatisfied nor satisfied" at the end of the 2-week run-in period.

        Exclusion Criteria:

          -  Patients currently taking rabeprazole 20mg once daily (morning or evening
             administration) or 10mg twice daily (morning and evening administration) on a
             continuous basis

          -  Documented evidence of GERD refractory to acid suppressive therapy (i.e.

          -  no or poor clinical response to at least two treatment courses of 4-weeks duration
             with a PPI)

          -  Esophagitis known to be the result of systemic events (e.g. scleroderma, ingested
             irritants)

          -  Active GI bleeding, or presence of "alarm symptoms" (i.e., vomiting, blood in stool,
             anemia, dysphagia)

          -  Documented history of significant pyloric stenosis or esophageal ring stricture

          -  Documented evidence of esophageal or gastric varices

          -  Patients with primary motility disorders, infectious or inflammatory conditions of the
             small or large intestine, malabsorption syndromes, GI obstruction, history of
             gastrointestinal malignancy, definitive acid-lowering surgery or other esophageal,
             gastric or intestinal surgery (including vagotomy) except for simple closure of
             perforation

          -  Patients who are unable or unwilling to discontinue the use of prostaglandins (e.g.
             misoprostol), sucralfate, prokinetic agents (e.g. metoclopramide), anticholinergics,
             cholinergic agents or spasmolytics. Use of opiates may be continued if started at
             least 2 weeks before study admission and the dosage is consistent (± 25% for total
             opioid daily dose) throughout the study

          -  Treatment with high-dose systemic corticosteroids (>10mg/day prednisone equivalent)
             and NSAIDs, including COX-2 selective inhibitors, cannot be initiated at anytime
             during the study. However, patients taking corticosteroids and NSAIDs (including ASA)
             before study entry may continue these medications during the study, however, they must
             have been taking a stable dose (e.g. for oral medication, a consistent daily dose ±
             25%) for at least 2 weeks before study admission and the dosage must be kept constant
             throughout the study. Occasional, intermittent use of NSAIDs for acute, self-limiting
             conditions (e.g. headache relief) is acceptable during the study

          -  >3 daytime episodes during any 7 consecutive days of the run-in period

          -  >1 severe or very severe daytime episode (i.e., more than 1 daytime heartburn episode
             rated >=3) during any 7 consecutive days of the run-in period

          -  Maximum total daytime heartburn score >5 during any 7 consecutive days of the run-in
             period.
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