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

Launched by TAKEDA · Nov 24, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called dexlansoprazole to see if it can safely heal a condition known as erosive esophagitis (EE) in children aged 2 to 11 years old. Erosive esophagitis happens when acid from the stomach damages the esophagus, the tube that carries food to the stomach. The trial aims to find out if dexlansoprazole can not only heal this damage but also help keep it from coming back.

To participate, children must have a history of symptoms related to gastroesophageal reflux disease (GERD), which is when stomach acid frequently moves up into the esophagus, causing pain and discomfort. They also need to have evidence of erosive esophagitis confirmed through an examination called an endoscopy. Parents or guardians will need to provide consent, and children who are old enough will also need to agree to participate. During the study, participants will receive the medication and will be monitored for its effectiveness and safety. This trial is a great opportunity for children struggling with this condition to potentially receive a treatment that could improve their health and quality of life.

Gender

ALL

Eligibility criteria

• 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 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.
• 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 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.