RECRUITING

A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE). Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of 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

Quick Facts

Study Start:2023-05-23

Study Completion:2027-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02615184

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 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). 5. Has endoscopic evidence of EE with Los Angeles (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. 6. Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent.	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 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 milligrams per deciliter (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 Helicobacter pylori.

Inclusion Criteria

Exclusion 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 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).
5. Has endoscopic evidence of EE with Los Angeles (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.
6. Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent.

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 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 milligrams per deciliter (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 Helicobacter pylori.

Contacts and Locations

Study Contact

Takeda Contact

CONTACT

+1-877-825-3327

medinfoUS@takeda.com

Principal Investigator

Study Director

STUDY_DIRECTOR

Takeda

Study Locations (Sites)

University of South Alabama

Mobile, Alabama, 36604

United States

University of California San Francisco

San Francisco, California, 94158

United States

D&H National Research Centers

Miami, Florida, 33155

United States

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, 30342

United States

Gastrointestinal Associates, PA

Flowood, Mississippi, 39232

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Measurable Outcome Research

Oklahoma City, Oklahoma, 73112

United States

GI for Kids

Knoxville, Tennessee, 37922

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

United States

Envision Clinical Research, LLC

Laredo, Texas, 78041

United States

The Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Takeda

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23

Study Completion Date2027-10-31

Study Record Updates

Study Start Date2023-05-23

Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

Drug therapy

Additional Relevant MeSH Terms

Erosive Esophagitis