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A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children

Primary Purpose

Erosive Esophagitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dexlansoprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Esophagitis focused on measuring Drug therapy

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. In the opinion of the investigator, the participant (as age appropriate) and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
  2. Prior to any study-specific procedures being performed, the appropriate screening informed consent and the assent forms (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 GERD for at least 3 months prior to Screening.
  4. Has medical history of at least 1 failed attempted withdrawal of prior PPI/acid-suppressive therapy with a return of symptoms upon withdrawal.
  5. 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. (Note: If an endoscopy performed within 1 week of signing screening informed consent and assent [as applicable] is used to confirm diagnosis of EE, the participant does not need to meet this criterion).
  6. Has endoscopic evidence of EE with LA Grade A to D based on the screening endoscopy performed either during the Screening Period or within 1 week prior to signing screening informed consent and assent (as applicable). An endoscopy that was performed within 1 week prior to signing screening informed consent and assent, as applicable, is an acceptable replacement for the Screening endoscopy if EE is documented by LA classification scale criterion previously described, protocol-required biopsies were collected and endoscopic pictures were obtained.
  7. Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent.

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 or any component of dexlansoprazole capsules 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 a known history of Barrett's with dysplastic changes in the esophagus.
  8. Has a known history of eosinophilic esophagitis (EoE) or 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 has 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. If present >4 weeks prior to Day -1, ulcers must not be present upon screening endoscopy.
  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 by Day -1.
  14. Is known to be positive for the human immunodeficiency virus (HIV).
  15. Has current or clinical history 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 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 (not including screening for Study TAK-390MR_204 [NCT02616302]) and/or has received any investigational compound within 30 days prior to Screening.
  24. Tests positive for H. pylori.

Sites / Locations

  • University of South AlabamaRecruiting
  • University of California San Francisco
  • D&H National Research CentersRecruiting
  • Children's Center for Digestive Health Care, LLCRecruiting
  • Gastrointestinal Associates, PARecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Measurable Outcome Research
  • GI for KidsRecruiting
  • Vanderbilt University Medical Center
  • Envision Clinical Research, LLCRecruiting
  • The Children's Hospital of The King's DaughtersRecruiting
  • Women and Children's Health Research Institute
  • London Health Sciences Centre (LHSC) - Children's Hospital
  • Hospital Universitario San Ignacio
  • Fundacion Valle del Lili
  • Centro Medico Imbanaco de Cali S.A
  • Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
  • Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public InstitutionRecruiting
  • Boca Clinical Trials Mexico SC
  • Clinical Research Institute S.C.Recruiting
  • Inspirepharma S. de R.L. de C.V.
  • El Cielo Medical CenterRecruiting
  • SMIQ S. de R.L. de C.V.Recruiting
  • In Vivo Osrodek Badan KlinicznychRecruiting
  • Uniwersytecki Szpital Dzieciecy w Krakowie
  • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Gabinet Lekarski Bartosz KorczowskiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Healing Period: Dexlansoprazole 60 mg

Healing Period: Dexlansoprazole 30 mg

Maintenance of Healed EE: Dexlansoprazole 30 mg

Maintenance of Healed EE: Dexlansoprazole 15 mg

Arm Description

Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.

Dexlansoprazole 30 mg, capsules, orally, once, daily, for 8 weeks.

Participants on Dexlansoprazole 60 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 30 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Participants on Dexlansoprazole 30 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 15 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Outcomes

Primary Outcome Measures

Percentage of Participants with Healing of Erosive Esophagitis (EE) by Week 8
Healing of EE will be assessed by endoscopy.
Percentage of Participants who Maintained Healed EE from Week 8 to Week 24
Percentage of participants who maintained healed EE from Week 8 to Week 24 among the participants who were healed at Week 8 as assessed by endoscopy.

Secondary Outcome Measures

Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 Weeks of Treatment
Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 Among Participants Who were Healed by Week 8
Daily eDiaries will be completed which contain PGSDD questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.

Full Information

First Posted
November 24, 2015
Last Updated
August 16, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02615184
Brief Title
A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children
Official Title
A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
November 17, 2027 (Anticipated)
Study Completion Date
November 17, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aims of the study are to check the side effects and effectiveness of Dexlansoprazole in healing erosive esophagitis (EE) side effects and effectiveness of Dexlansoprazole in maintaining healed EE in children. Participants will take Dexlansoprazole by mouth.
Detailed Description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal EE and maintain healing of EE in pediatric participants aged 2 to 11 years. This study will look at the healing of EE followed by maintained healing of EE in children who take dexlansoprazole. The study will be conducted in two periods; a Healing of EE Period and a Maintenance of Healed EE Period. Approximately 76 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 mg or dexlansoprazole 30 mg for 8 weeks during the Healing of EE Period. Following Week 8, participants will enter the Maintenance of Healed EE Period and will receive half their healing dose of dexlansoprazole, (i.e., either 30 mg, dexlansoprazole 15 mg). All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have heartburn symptoms in a diary. Participants who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24) and have maintained healing of EE as confirmed by endoscopy, will enter a Post-Treatment Follow up Period for up to 3 months after the last dose of study drug. During this period participants will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Participants who require an invasive procedure or treatment with a proton pump inhibitor (PPI) or histamine 2-receptor antagonist (H2RA) for gastroesophageal reflux disease (GERD)/EE will be discontinued from the Post-Treatment Follow-up Period and a Final Study Visit will be performed. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 10 months. Participants will make multiple visits to the clinic including a final visit 3 months after last dose of study drug for a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healing Period: Dexlansoprazole 60 mg
Arm Type
Experimental
Arm Description
Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.
Arm Title
Healing Period: Dexlansoprazole 30 mg
Arm Type
Experimental
Arm Description
Dexlansoprazole 30 mg, capsules, orally, once, daily, for 8 weeks.
Arm Title
Maintenance of Healed EE: Dexlansoprazole 30 mg
Arm Type
Experimental
Arm Description
Participants on Dexlansoprazole 60 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 30 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.
Arm Title
Maintenance of Healed EE: Dexlansoprazole 15 mg
Arm Type
Experimental
Arm Description
Participants on Dexlansoprazole 30 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 15 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
Dexlansoprazole capsules
Primary Outcome Measure Information:
Title
Percentage of Participants with Healing of Erosive Esophagitis (EE) by Week 8
Description
Healing of EE will be assessed by endoscopy.
Time Frame
Week 8
Title
Percentage of Participants who Maintained Healed EE from Week 8 to Week 24
Description
Percentage of participants who maintained healed EE from Week 8 to Week 24 among the participants who were healed at Week 8 as assessed by endoscopy.
Time Frame
Week 8 to Week 24
Secondary Outcome Measure Information:
Title
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 Weeks of Treatment
Description
Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.
Time Frame
Week 8
Title
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 Among Participants Who were Healed by Week 8
Description
Daily eDiaries will be completed which contain PGSDD questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.
Time Frame
Weeks 8 to 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the opinion of the investigator, the participant (as age appropriate) and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements. Prior to any study-specific procedures being performed, the appropriate screening informed consent and the assent forms (as applicable) must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate. Has a medical history of symptoms of GERD for at least 3 months prior to Screening. Has medical history of at least 1 failed attempted withdrawal of prior PPI/acid-suppressive therapy with a return of symptoms upon withdrawal. 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. (Note: If an endoscopy performed within 1 week of signing screening informed consent and assent [as applicable] is used to confirm diagnosis of EE, the participant does not need to meet this criterion). Has endoscopic evidence of EE with LA Grade A to D based on the screening endoscopy performed either during the Screening Period or within 1 week prior to signing screening informed consent and assent (as applicable). An endoscopy that was performed within 1 week prior to signing screening informed consent and assent, as applicable, is an acceptable replacement for the Screening endoscopy if EE is documented by LA classification scale criterion previously described, protocol-required biopsies were collected and endoscopic pictures were obtained. Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent. Exclusion Criteria: 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. 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. 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. Has a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole capsules or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacids. 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. Has a condition that may require inpatient surgery during the course of the study. Has a known history of Barrett's with dysplastic changes in the esophagus. Has a known history of eosinophilic esophagitis (EoE) or endoscopic or histologic findings suggestive of EoE (≥15 eosinophils per high-powered field [HPF]). Has history of celiac disease, tests positive for tissue transglutaminase (tTG) antibody, or has confirmed disease by histology. Has history of inflammatory bowel disease, or irritable bowel syndrome. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present >4 weeks prior to Day -1, ulcers must not be present upon screening endoscopy. 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. A female participant who has reached menarche by Day -1. Is known to be positive for the human immunodeficiency virus (HIV). Has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition. 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. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy. 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. Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug. 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. 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 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. The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason. Has participated in another clinical study (not including screening for Study TAK-390MR_204 [NCT02616302]) and/or has received any investigational compound within 30 days prior to Screening. Tests positive for H. pylori.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
251-434-3919
Email
dgremse@health.southalabama.edu
First Name & Middle Initial & Last Name & Degree
David Gremse
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
415-502-2045
Email
yvette.wild@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Yvette Wild
Facility Name
D&H National Research Centers
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
786-375-6210
Email
drslevy@dhnrc.com
First Name & Middle Initial & Last Name & Degree
Shoshanah Levy
Facility Name
Children's Center for Digestive Health Care, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
404-257-0799
Email
jgarza@gicareforkids.com
First Name & Middle Initial & Last Name & Degree
Jose Garza
Facility Name
Gastrointestinal Associates, PA
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
601-863-0395
Email
sara.rippel@gastrodocs.net
First Name & Middle Initial & Last Name & Degree
Sara Rippel
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-844-3310
Email
thomas.sferra@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Thomas Sferra
Facility Name
Measurable Outcome Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
405-949-4139
Email
mshambay@gmail.com
First Name & Middle Initial & Last Name & Degree
Maryam Shambayati
Facility Name
GI for Kids
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
865-546-3998
Email
yaltawil@giforkids.com
First Name & Middle Initial & Last Name & Degree
Youhanna Al-Tawil
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
615-343-9034
Email
sari.acra@vumc.org
First Name & Middle Initial & Last Name & Degree
Sari Acra
Facility Name
Envision Clinical Research, LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
956-795-8366
Email
aramos.soriano@stexresearch.com
First Name & Middle Initial & Last Name & Degree
Asuncion Ramos Soriano
Facility Name
The Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
757-668-7000
Email
michael.konikoff@chkd.org
First Name & Middle Initial & Last Name & Degree
Michael Konikoff
Facility Name
Women and Children's Health Research Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(780) 248-5420
Email
hien.huynh@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Hien Huynh
Facility Name
London Health Sciences Centre (LHSC) - Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(519) 685-8354
Email
kevin.bax@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Kevin Bax
Facility Name
Hospital Universitario San Ignacio
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
576314088
Email
ceplata@husi.org.co
First Name & Middle Initial & Last Name & Degree
Clara Eugenia Plata Garcia
Facility Name
Fundacion Valle del Lili
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
5723152916
Email
factibilidades@fvl.org.co
First Name & Middle Initial & Last Name & Degree
Veronica Botero
Facility Name
Centro Medico Imbanaco de Cali S.A
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
5726821000
Email
mairasanchez@yahoo.com
First Name & Middle Initial & Last Name & Degree
Maira Patricia Sanchez Perez
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
37037787393
Email
rutadrk@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruta Kucinskiene
Facility Name
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public Institution
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
37052492401
Email
vaidotas.urbonas@santa.lt
First Name & Middle Initial & Last Name & Degree
Vaidotas Urbonas
Facility Name
Boca Clinical Trials Mexico SC
City
Colonia Las Americas
State/Province
Distrito Federal
ZIP/Postal Code
1120
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(552) 648-5458
Email
atrevinomd@brcrclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Angelica Trevino Mateos
Facility Name
Clinical Research Institute S.C.
City
Tlalnepantla
State/Province
Estado De Mexico
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+52 55 53627780
Email
jcadenacri@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jose Francisco Cadena Leon
Facility Name
Inspirepharma S. de R.L. de C.V.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64660
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
528119725111
Email
murquidir@gmail.com
First Name & Middle Initial & Last Name & Degree
Martha Eugenia Urquidi Rivera
Facility Name
El Cielo Medical Center
City
Puebla
ZIP/Postal Code
72160
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
525527241809
Email
amartinezmd@brcrclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Alfredo Martinez Vazquez
Facility Name
SMIQ S. de R.L. de C.V.
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
524424765840
Email
marthasanchezmd@brcrclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Martha Paola Sanchez Soto
Facility Name
In Vivo Osrodek Badan Klinicznych
City
Bydgoszcz
State/Province
Kuyavia
ZIP/Postal Code
85-048
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
48601657377
Email
pkorbal@cm.umk.pl
First Name & Middle Initial & Last Name & Degree
Piotr Korbal
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48126582011 x1440
Email
misladek@cyfronet.pl
First Name & Middle Initial & Last Name & Degree
Malgorzata Sladek
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
State/Province
Masovia
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
48500111648
Email
j.kierkus@wip.waw.pl
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kierkus
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
48604481752
Email
korczowski@op.pl
First Name & Middle Initial & Last Name & Degree
Bartosz Korczowski

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b602f4db2bf003ab49d28?idFilter=%5B%22TAK-018-2001%22%2C%22TAK-390MR_205%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children

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