Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
70
Countries
1
Sites
3
Symptomatic nonerosive GERD in paediatric subjects aged 2 to 11 years
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 2 to 11 years with symptomatic nonerosive GERD
Key facts
- Sponsor
- Takeda Development Center Americas Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Jan 2026 → ongoing
- Decision date (initial)
- 2024-04-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Takeda Development Center Americas, Inc.
External identifiers
- EU CT number
- 2022-501349-64-00
- EudraCT number
- 2014-004506-15
- ClinicalTrials.gov
- NCT02616302
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety
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 2 to 11 years with symptomatic nonerosive GERD
Conditions and MedDRA coding
Symptomatic nonerosive GERD in paediatric subjects aged 2 to 11 years
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10066874 | Gastroesophageal reflux disease | 10017947 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Screening period up to 28 days
|
Not Applicable | None | ||
| 2 | Treatment Period Treatment Period - 12 weeks
|
Randomised Controlled | Double | [{"id":123693,"code":2,"name":"Investigator"},{"id":123694,"code":1,"name":"Subject"},{"id":123691,"code":5,"name":"Carer"},{"id":123690,"code":4,"name":"Analyst"},{"id":123692,"code":3,"name":"Monitor"}] | 15mg Dexlansoprazole: Subjects who weigh ≤30 kg will be randomized to receive dexlansoprazole 15 or 30 mg 30mg Dexlansoprazole: Subjects who weigh ≤30 kg will be randomized to receive dexlansoprazole 15 or 30 mg Subjects who weigh >30 kg will be randomized to receive dexlansoprazole 30 or 60 mg 60mg Dexlansoprazole: Subjects who weigh >30 kg will be randomized to receive dexlansoprazole 30 or 60 mg |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Medical history of GERD symptoms for at least 3 months prior to Screening.
- 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.
- 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 8
- Erosive esophagitis.
- History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
- 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.
- 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.
- Known history of Barrett's esophagus with dysplastic changes in the esophagus.
- 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.
- Active gastric or duodenal ulcers within 4 weeks prior to Day -1.
- Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.
Secondary endpoints 6
- 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.
- 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.
- Percentage of days without vomiting over the 12 weeks of treatment.
- Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment.
- Percentage of days without trouble eating over the 12 weeks of treatment.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10751437 · Product
- Active substance
- Dexlansoprazole
- Pharmaceutical form
- CAPSULE, PROLONGED RELEASE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- TAKEDA DEVELOPMENT CENTER AMERICAS, INC.,
- Paediatric formulation
- Yes
- Orphan designation
- No
PRD10751436 · Product
- Active substance
- Dexlansoprazole
- Pharmaceutical form
- CAPSULE, PROLONGED RELEASE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- TAKEDA DEVELOPMENT CENTER AMERICAS, INC.,
- Paediatric formulation
- Yes
- Orphan designation
- No
PRD10751438 · Product
- Active substance
- Dexlansoprazole
- Pharmaceutical form
- CAPSULE, PROLONGED RELEASE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- TAKEDA DEVELOPMENT CENTER AMERICAS, INC.,
- Paediatric formulation
- Yes
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Takeda Development Center Americas Inc.
- Sponsor organisation
- Takeda Development Center Americas Inc.
- Address
- 500 Kendall Street
- City
- Cambridge
- Postcode
- 02142-1108
- Country
- United States
Scientific contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Even Huang
Public contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Takeda Development Center Americas Inc.
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Cambridge Cognition Limited ORG-100045478
|
Cambridge, United Kingdom | E-data capture |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 11, Code 12, Code 2, Data management |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Laboratory analysis |
| Evidera Inc. ORG-100028146
|
Bethesda, United States | Other |
| Ppd Inc. ORG-100018960
|
Morrisville, United States | Laboratory analysis |
| Ppd Inc. ORG-100018960
|
Wilmington, United States | Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Bolton, United States | Other |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 20 | 3 |
| Rest of world
Colombia, United States, Mexico, Canada
|
— | 50 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2023-02-01 | 2023-03-15 | 2026-04-17 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-105940
- Halt date
- 2025-10-28
- Member states concerned
- Poland
- Publication date
- 2025-11-11
- Reason
- Sponsor decision
- Explanation
- During a recent IVDR compliance review, the Sponsor identified three tests that do not meet IVDR requirements. As outlined in the study protocol, these tests are only to be used in the event of liver test abnormalities occurring in a subject post-enrollment:
• Liver-Kidney Microsome Antibody, IgG (ARUP)
• Hepatitis E Virus by Quantitative PCR
• Epstein-Barr Virus Antibody - Follow-up measures
- To date, these non-IVDR compliant tests have not been utilized, and therefore no follow-up actions are required for any enrolled subjects. Nevertheless, proactive measures are being implemented to ensure that IVDR-compliant tests are available moving forward, in alignment with regulatory requirements.
As a precautionary step, subject recruitment has been temporarily paused in Poland. All other study activities continue as per the approved protocol, including recruitment in all other regions outside of the EU. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501349-64-00_red | Am 3 |
| Protocol (for publication) | D4_ Patient facing documents_placeholder_2022-501349-64-00_san | NA |
| Protocol (for publication) | D5_Justification for inclusion of minors_2022-501349-64-00 _red_san | NA |
| Recruitment arrangements (for publication) | K1_Patient Recruitment Procedure_PL_san | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Brochure_PL_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Parent Flyer_PL_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Parent Letter_PL_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 6-11_PL_san | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent over 12 yrs_PL_san | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Picture Book under 6 yrs_PL_san | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Screening 6-11_PL_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent Screening_PL_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent_PL_san | V3.0POL1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_en-2022-501349-64-00_san | Am 3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PL-pl-2022-501349-64-00_san | Am 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | Poland | Acceptable 2024-04-02
|
2024-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-16 | Poland | Acceptable 2024-09-09
|
2024-09-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-20 | Poland | Acceptable 2024-09-09
|
2025-05-20 |