Clinical trial: A Phase 2 Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Pediatric Subjects Aged 1 to 11 Years (NCT02616302)

Eligibility criteria:
Inclusion Criteria:

          1. In the opinion of the investigator, the participant (as age appropriate) and/or
             parent(s)/legal guardian is capable of understanding and complying with protocol
             requirements.

          2. Prior to any study-specific procedures being performed, the informed consent and the
             assent form (as applicable) must be signed and dated by parent(s) or legal guardian
             and by the participant respectively, if appropriate.

          3. Has a medical history of symptoms of gastroesophageal reflux disease (GERD) for at
             least 3 months prior to Screening.

          4. Has a medical history of at least 1 failed attempted withdrawal of prior proton pump
             inhibitor (PPI)/acid suppressive therapy and a return of symptoms upon withdrawal.

          5. Has met the electronic diary (eDiary) qualification criteria as assessed by the
             Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD), defined as
             hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive
             days during the Screening Period.

          6. Has either (1) a positive endoscopy with both a Hetzel-Dent (HD) Grade 1 and a
             Histologic Features of Reflux Esophagitis (HFRE) Scale Grade <2, OR (2) an endoscopy
             with HD Grade 0 and a documented pH-metry suggestive of acid-related disease. The
             pH-metry should be performed during Screening or within 6 months of signing informed
             consent and assent (as applicable) for GERD symptoms. An endoscopy performed within 1
             week prior to signing informed consent and assent (as applicable), is an acceptable
             replacement for the screening endoscopy if GERD is documented by the HD classification
             scale criterion previously described, protocol-required biopsies were collected and
             endoscopic pictures were obtained.

          7. Is male or female and age 1 to 11 years inclusive at Screening.

        Exclusion Criteria:

          1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,
             hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin
             rash that suggests any uncontrolled, clinically significant underlying disease or
             condition (other than the disease being studied), which may impact the ability of the
             participant to participate or potentially confound the study results.

          2. Has a coexisting disease affecting the esophagus (eg, esophageal varices, scleroderma,
             viral or fungal infection, or esophageal stricture), history of radiation therapy or
             cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy
             to the esophagus.

          3. Has any findings in his/her medical history, physical examination, or safety clinical
             laboratory tests giving reasonable suspicion of underlying disease that might
             interfere with the conduct of the trial.

          4. Has a history of hypersensitivity or allergies to dexlansoprazole, any component of
             dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole,
             pantoprazole, or esomeprazole) or antacids.

          5. Is required to take excluded medications or it is anticipated that the participant
             will require treatment with at least 1 of the disallowed concomitant medications
             during the study evaluation period.

          6. Has a condition that may require inpatient surgery during the course of the study.

          7. Has known history of Barrett's esophagus with dysplastic changes in the esophagus.

          8. Has history of eosinophilic esophagitis (EoE) endoscopic or histologic findings
             suggestive of EoE (>15 eosinophils per high-powered field [HPF])

          9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG)
             antibody or confirmed disease by histology.

         10. Has history of inflammatory bowel disease, or irritable bowel syndrome.

         11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

         12. Requires dilatation of 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.

         13. A female participant who has reached menarche.

         14. Is known to be positive for the human immunodeficiency virus (HIV).

         15. Has current or historical evidence of Zollinger-Ellison syndrome or other
             hypersecretory condition.

         16. Has a history of gastric, duodenal, or esophageal surgery except simple oversew of an
             ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)
             placement is allowed.

         17. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

         18. Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or has
             had a transfusion of any blood product within 90 days prior to the first dose of study
             drug.

         19. Has a known history of alcohol abuse or illegal drug use within the past 12 months
             prior to the first dose of study drug.

         20. Has any screening abnormal laboratory value that suggests a clinically significant
             underlying disease or condition that may prevent the participant from entering the
             study; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT)
             and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN), or
             total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.

         21. Is an immediate family member, study site employee, or is in a dependent relationship
             with a study site employee who is involved in the conduct of this study or may consent
             and assent (as applicable) under duress. Students of the institution/research facility
             who are under the supervision of, or in a subordinate role to, the investigator are
             also ineligible.

         22. The participant, in the opinion of the investigator, is unlikely to comply with the
             protocol or is unsuitable for any other reason.

         23. Has participated in another clinical study and/or has received any investigational
             compound within 30 days prior to Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 11 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