Symptomatic nonerosive GERD in paediatric subjects aged 1 to 11 years MedDRA version: 18.1 Level: LLT Classification code 10066874 Term: Gastroesophageal reflux disease System Organ Class: 100000004856
Conditions
Sponsors
Takeda Development Centre Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. In the opinion of the investigator, the subject (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 subject respectively, if appropriate. 3. The subject has a medical history of symptoms of GERD for at least 3 months prior to Screening. 4. The subject has a medical history of at least 1 failed attempted withdrawal of prior PPI/acid suppressive therapy and a return of symptoms upon withdrawal. 5. The subject has met the eDiary qualification criteria as assessed by the 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. Subject has either (1) a positive endoscopy with both a HD Grade 1 and a HFRE Scale Grade =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject who meets any of the following criteria will not qualify for entry into the study: 1. The subject 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 subject to participate or potentially confound the study results. 2. The subject has a coexisting disease affecting the esophagus (eg, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy orcryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. 3. The subject 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. The subject 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. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medication section of the study protocol. 6. The subject has a condition that may require inpatient surgery during the course of the study. 7. The subject has known history of Barrett’s esophagus with dysplastic changes in the esophagus. 8. The subject has history of eosinophilic esophagitis (EoE) endoscopic or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]) 9. The subject has history of celiac disease, tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology. 10. The subject has history of inflammatory bowel disease, or irritable bowel syndrome. 11. The subject has active gastric or duodenal ulcers within 4 weeks prior to Day -1. 12. The subject 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 subject who has reached menarche. 14. The subject is known to be positive for the human immunodeficiency virus (HIV). 15. The subject has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition. 16. The subject 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. The subject had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy. 18. The subject 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. The subject 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. The subject has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the subject from enterin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and effectiveness of treatment with QD oral administration of dexlansoprazole delayed release capsules (15,30, and 60 mg) in pediatric subjects aged 1 to 11 years with symptomatic nonerosive GERD;Secondary Objective: none;Primary end point(s): The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The proportion of subjects with Hetzel-Dent (HD) Grade 0 at Week 12 among subjects with HD classification scale Grade 1 and Histologic Features of Reflux Esophagitis (HFRE) Grade =2 at Baseline. 2) Percentage of days without hurting or burning in the stomach, chest or throat in children aged 9 to 11 years over the 12 weeks of treatment. 3) Percentage of days without hurting or burning in the stomach, chest or throat in children aged 1 to 8 years over the 12 weeks of treatment. 4) Percentage of days without vomiting over the 12 weeks of treatment. 5) Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment. 6) Percentage of days without trouble eating over the 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Belgium, Brazil, Israel, Italy, Lithuania, Mexico, Poland, Portugal, United States
Contacts
Public ContactProgram Manager
Takeda Development Centre Europe Ltd.
Outcome results
None listed