Clinical trial: Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients (NCT02873689)

Eligibility criteria:
Inclusion Criteria:

          1. Participants identifying their main symptom as a burning feeling in the mid-epigastric
             area and/or chest area (that is, heartburn).

          2. Must have a history of symptomatic GERD for 6 months or longer prior to Screening with
             GERD symptoms that were responsive to acid-suppressive therapy.

          3. Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1
             as recorded in the eDiary.

        Exclusion Criteria:

          1. Has a history of cancer (except basal cell carcinoma of the skin), that has not been
             in remission for at least 5 years prior to Screening.

          2. Has a known history of Barrett's esophagus with dysplastic changes or any changes
             suspicious Barrett's seen during screening endoscopy.

          3. Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal
             defect with white coating) or duodenal ulcer (a mucosal defect with white coating),
             within 30 days before the start of the Screening Visit (with the possible inclusion of
             those with gastric or duodenal erosion). The participant requires chronic use (greater
             than [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs)
             including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period
             and throughout the study.

          4. Has comorbidities that could affect the esophagus (eosinophilic esophagitis,
             esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a
             history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or
             physiochemical injury (with the possible inclusion in the study of those with
             Schatzki's ring).

          5. Has a history of surgical procedures that may affect the esophagus (example,
             fundoplication and mechanical dilatation for esophageal strictures) or a history of
             gastric or duodenal surgery other than endoscopic removal of benign polyps.

          6. Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.

          7. Is known to have acquired immunodeficiency syndrome (AIDS) or hepatitis, including
             hepatitis virus carriers: (that is, hepatitis B surface antigen HBs-antigen (HBsAg)
             positive or hepatitis C virus (HCV)-antibody positive).

          8. Has current or historical evidence of Zollinger-Ellison syndrome or a history of
             gastric acid hypersecretion.

          9. Is scheduled for surgery that requires hospitalization or requires surgical treatment
             during his/her participation in the study.

         10. Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or
             has had a transfusion of any blood product within 90 days prior to the first dose of
             study drug.

         11. Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction in
             the 12 months prior to Screening.

         12. Participant with positive serology result of Helicobacter pylori (H. pylori) that
             needs eradication therapy during the study participation period as anticipated by the
             investigator.
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