Clinical trial: A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn (NCT00627016)

Eligibility criteria:
Inclusion Criteria:

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  History of nocturnal heartburn and GERD associated sleep disturbances prior to
             screening.

          -  Meets both of the following criteria: 1) nocturnal heartburn severity of moderate,
             severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep
             disturbances on at least 3 of 7 nights.

          -  Subjects must have history of symptomatic GERD prior to screening with GERD symptoms
             that were responsive to acid-suppressive therapy.

        Exclusion Criteria:

          -  Erosive esophagitis visualized during the screening endoscopy.

          -  Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole,
             pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.

          -  Active gastric or duodenal ulcers within 30 days prior to randomization.

          -  Upper gastrointestinal bleeding within 6 months prior to randomization.

          -  Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal
             varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).

          -  History of radiation therapy or cryotherapy to the esophagus, caustic or
             physiochemical trauma such as sclerotherapy to the esophagus.

          -  Subject requiring dilation for esophageal strictures and/or strictures preventing
             passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of
             mucosal tissue near the lower esophageal sphincter) is acceptable.

          -  Has another condition that could be the primary cause of the subject's sleep
             disturbance.

          -  Evidence of uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality (other than the disease being studied) which may impact the ability of the
             subject to participate or potentially confound the trial results.

          -  Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.

          -  Has a condition likely to require surgery during the study.

          -  Currently diagnosed with acquired immunodeficiency syndrome (AIDS).

          -  Abnormal clinical laboratory values.

          -  History of alcoholism or drug addiction.

          -  Subject who works the night shift.

          -  Subject who is planning to travel beyond 3 time zones during the study.

          -  Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs
             (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to
             randomization or anticipated use during the study.

          -  Use of the following medications during the 14 days prior to randomization or
             anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol,
             corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other
             than stable doses), psychotropic medications (other than stable doses), narcotic
             medications (occasional use allowed), bisphosphonates.

          -  Use of sleep medications, first generation antihistamines, benzodiazepines, modified
             cyclic antidepressants, antianxiety medications or drugs with significant
             anticholinergic effects such as tricyclic antidepressants or drugs with central
             nervous system effects that could mask perception of symptoms (eg, selective-serotonin
             reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However,
             subjects who remain on a stable regimen and dose of these medications during the 90
             days prior to randomization and who agree to maintain the same regimen and dose during
             the trial will qualify. Also, short term use of anticholinergics for trial related
             procedures is not exclusionary. Second generation antihistamines are not excluded.

          -  Use of histamine (H2) receptor antagonists or antacids (except for trial supplied
             Gelusil) during the screening period or anticipated use during the treatment 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.
Subject must be at most 65 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? Entailment