DEXLANSOPRAZOLE for Nonerosive gastroesophageal reflux disease

Stratification factors

• weight (<=30 kg vs >30 kg)

Inclusion criteria

• {"criterion_text":"- Medical history of GERD symptoms for at least 3 months prior to Screening.\n- Reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days as recorded in the eDiary during screening.\n- No evidence of erosive esophagitis according to the LA Classification of Esophagitis and, in the investigator's clinical judgment, the symptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or without impedance) may be performed during Screening or within 6 months prior to Screening for similar symptoms as those identified during Screening if, in the investigator's judgment, this procedure would aid in the determination of whether the subject's symptoms are acid related."}

Exclusion criteria

• {"criterion_text":"- Erosive esophagitis.\n- History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).\n- 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.\n- Any findings in medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.\n- Known history of Barrett's esophagus with dysplastic changes in the esophagus.\n- History of the following: eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]); a history of celiac disease or tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology; inflammatory bowel disease; or irritable bowel syndrome.\n- Active gastric or duodenal ulcers within 4 weeks prior to Day -1.\n- Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3)."}

Primary endpoints

• {"endpoint_text":"- The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.","definition_or_measurement_approach":"Measured as the percentage of days over the 12-week treatment period without reported hurting or burning in the stomach, chest, or throat (assessment period = 12 weeks)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as the percentage of days over the 12-week treatment period without reported hurting or burning, analyzed in the 9–11 year age subgroup."}
• {"endpoint_text":"- Percentage of days without hurting or burning in the stomach, chest or throat in children aged 2 to 8 years over the 12 weeks of treatment.","definition_or_measurement_approach":"Measured as the percentage of days over the 12-week treatment period without reported hurting or burning, analyzed in the 2–8 year age subgroup."}
• {"endpoint_text":"- Percentage of days without vomiting over the 12 weeks of treatment.","definition_or_measurement_approach":"Measured as the percentage of days with no vomiting reported during the 12-week treatment period."}
• {"endpoint_text":"- Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment.","definition_or_measurement_approach":"Measured as the percentage of days during the 12-week period when reflux of food to the mouth did not occur, as reported."}
• {"endpoint_text":"- Percentage of days without trouble eating over the 12 weeks of treatment.","definition_or_measurement_approach":"Measured as the percentage of days during the 12-week treatment period without reported difficulty eating."}
• {"endpoint_text":"- Comparison of the difference of the mean percentage of days without hurting or burning in the stomach, chest, or throat over the 12 weeks of treatment between the high dose and the low dose within each weight strata.","definition_or_measurement_approach":"Statistical comparison of mean percentage of days without hurting/burning between high- and low-dose arms within predefined weight strata over the 12-week treatment period."}

Methods

• Parent brochure (K2_Recruitment material_Parent Brochure_PL_san) — parent/guardian-facing recruitment material listed for Poland.
• Parent flyer (K2_Recruitment material_Parent Flyer_PL_san) — parent/guardian-facing recruitment flyer listed for Poland.
• Study parent letter (K2_Recruitment material_Study Parent Letter_PL_san) — parent/guardian contact letter listed for Poland.
• Patient Recruitment Procedure (K1_Patient Recruitment Procedure_PL_san) — procedural document for recruitment activities (Poland).

Poland

Earliest CTIS Part Ii Submission Date

23-02-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

206

Number Of Sites

3

Number Of Participants

20

Primary sponsor

Full Name

Takeda Development Center Americas Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Operational and clinical trial services (sponsorDuties codes: [1,11,12,2,6]); contact eu_clinical_trials_information@iqvia.com

Name

Ppd Inc. / PPD Global Central Labs

Responsibilities

Central lab and trial support (sponsorDuties codes: [4]); contact Cynthia.Edwards@ppd.com

Name

Endpoint Clinical Inc.

Responsibilities

IVRS/treatment randomisation (sponsorDuties code: [15]); contact ovalle@endpointclinical.com

Name

WCG Clinical Inc.

Responsibilities

Medical image analysis/review (sponsorDuties code: [15]); contact awilmer@wcgclinical.com

Name

Evidera Inc.

Responsibilities

ePRO Psychometric Analysis Plan (sponsorDuties code: [15]); contact miriam.kimel@evidera.com

Third parties

• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: [4]; contact email: Cynthia.Edwards@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Cambridge Cognition Limited","duties_or_roles":"sponsorDuties codes: [7]; contact email: Julie-Ann.Marshall@camcog.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,2,6]; contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: sean.gemmill@neogenomics.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Evidera Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: ePRO Psychometric Analysis Plan; contact email: miriam.kimel@evidera.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: Cynthia.Edwards@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: Cynthia.Edwards@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: IVRS30 – treatment randomisation; contact email: ovalle@endpointclinical.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Medical image analysis/ review - X-ray, MRI,ultrasound, etc.; contact email: awilmer@wcgclinical.com","organisation_type":"Pharmaceutical company"}