Clinical trial: Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease (NCT02351960)

Eligibility criteria:
Inclusion Criteria: -

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements

          2. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any procedures

          3. Has persistent typical gastroesophageal reflux disease (GERD) symptoms (heartburn
             and/or acid regurgitation) for at least 6 months and a frequency of GERD symptoms is
             at least 4 days within the past 7 days prior to the screening visit

          4. Meets one of the following diagnoses verified by the screening endoscopy

               1. Has macroscopically normal esophageal mucosa on endoscopy and may thereby be
                  eligible for assignment to the nonerosive reflux disease (NERD) study group

               2. Has evidence of erosive esophageal reflux disease on endoscopy, Los Angeles (LA)
                  classification grades B-D, and thereby may be eligible for assignment to the
                  erosive esophagitis (EE) study group

          5. Is able and willing to record GERD symptoms in a subject diary and has completed the
             diary at least for 7 consecutive days during the screening period

          6. Male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 30 days after last dose

          7. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent throughout the duration of the study

          8. All female participants of childbearing potential must have a negative urine pregnancy
             test at Screening and a negative urine pregnancy test at Day -1. Participants who have
             had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of
             menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level >40 IU/L or
             absence of menses for >2 years) are not required to use birth control

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to Screening

          2. Known hypersensitivity to any proton pump inhibitor (including lansoprazole,
             omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of
             dexlansoprazole

          3. Use of a H2 blocker or a PPI other than dexlansoprazole during screening and
             throughout the study. Previous use of Dexlansoprazole before screening

          4. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

          5. Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug

          6. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring
             of mucosal tissue near the lower esophageal sphincter)

          7. Co-existing diseases affecting the esophagus, (eg, esophageal varices, scleroderma,
             viral, fungal infection or esophageal stricture), history of radiation therapy or
             cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy
             to the esophagus

          8. Chronic use (>12 doses/month) of non-;steroidal anti-inflammatory drugs (NSAIDs)
             including COX 2 NSAIDs within 30 days prior to screening period and throughout the
             study, however, low dose aspirin up to 325 mg per day is allowed

          9. In the judgment of the investigator, participant has clinically significant abnormal
             hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening

         10. Has a history or clinical manifestations of significant organ failure which would
             preclude their successful completion of the study

         11. Participants using drugs with significant anticholinergic effects such as tricyclics
             who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study

         12. Participants with known biliary disease

         13. Participants with the need for continuous anticoagulant therapy

         14. Participants with cancer (except basal cell and squamous cell carcinoma of the skin)
             within 3 years prior to Screening

         15. Any condition that may require inpatient surgery during the course of the study

         16. Has abnormal laboratory values that suggest a clinically significant underlying
             disease or condition that may prevent the subject from entering the study; or subject
             with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase
             (ALT) and/or Aspartate Aminotransferase (AST) >2.0X the upper limits of normal, or
             Total Bilirubin >2.0 mg/dL with AST/ALT elevated above normal values

         17. Known to have acquired immunodeficiency syndrome (AIDS)

         18. Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory
             condition

         19. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer

         20. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of endoscopy

        22. Has received blood products within 3 months prior to the first dose of study drug 23.
        History of alcohol abuse [>21 units (1 unit = 12 oz beer, 1.5 oz hard liquor, or 5 oz wine)
        per week] or illegal drug use or drug addiction in the 12 months prior to Screening 24.
        Participants who, in the opinion of the investigator, are unable to comply with the
        requirements of the study or are unsuitable for any reason 25. is required to take excluded
        medications 26. If female, the participant is pregnant or lactating or intending to become
        pregnant before, during, or within 1 month after participating in this study; or intending
        to donate ova during such time period 27. If male, the participant intends to donate sperm
        during the course of this study or for 30 days thereafter
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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