Clinical trial: Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD (NCT03444883)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female aged ≥ 19 years and ≤ 80 years

          2. Diagnosed with non-erosive reflux disease meeting all of the following criteria:

             2-1) At least either heartburn or acid regurgitation has persisted for at least past 3
             months before screening 2-2) Have experienced at least either heartburn or acid
             regurgitation of moderate or higher intensity on at least 2 days of 7 days prior to
             initiation of the investigational product 2-3) Esophageal mucosal breaks by LA
             Classification are not observed on upper gastrointestinal endoscopy at screening

          3. Voluntarily provide written informed consent to participate in this study

        Exclusion Criteria:

          1. Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus
             confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening

          2. Active peptic ulcer or gastrointestinal bleeding confirmed by past upper
             gastrointestinal endoscopy at screening or within 4 weeks prior to screening

          3. Abnormal value on laboratory test at screening:

             3-1) Total Bilirubin, Creatinine > Upper limit of normal (ULN) x 1.5 3-2) Alkaline
             Phosphatase, BUN > ULN x 2

          4. Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC,
             second-degree or higher AV block, etc.) within 3 months prior to screening

          5. Have taken H2 receptor antagonists (H2RA), prostaglandin preparations, mucosal
             protective drugs, prokinetics, etc. within 2 weeks prior to initiation of the
             investigational product administration, or has taken PPIs within 4 weeks prior to
             initiation of the investigational product administration

          6. Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including
             aspirin or steroid preparations during the study

          7. Surgical or medical condition that may significantly influence the absorption,
             distribution, metabolism or excretion of drug, including but not limited to: history
             of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, colectomy,
             gastric bypass, gastric ligation or gastric banding; presence or history of active
             inflammatory bowel disease within 12 months prior to screening; has undergone critical
             surgery that may influence gastric acid secretion with exception of surgeries such as
             appendectomy, cholecystectomy, and hysterectomy

          8. Zollinger-Ellison syndrome; past history of alcoholism or drug abuse

          9. Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to
             any ingredient of the Investigational product

         10. Past history of treated or untreated malignancy, with or without local recurrence or
             metastasis, within 5 years prior to screening (with exception of local basal cell
             carcinoma of skin)

         11. Pregnant or nursing women

         12. Women of childbearing potential who do not use proper contraception during the study

         13. Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic
             encephalopathy, esophageal varix, or portacaval shunt

         14. Receiving renal dialysis or history of kidney transplantation or presence of severe
             renal impairment (stage 4 or 5 chronic renal disease)

         15. Participated in another clinical study and took an investigational product within 3
             months prior to screening

         16. Considered by the investigator to be ineligible to participate in this study for other
             reasons
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 80 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? 0