Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn
Intervention: Dexlansoprazole; Dexlansoprazole; Placebo
Intervention description: Dexlansoprazole capsules; Dexlansoprazole capsules; Dexlansoprazole placebo-matching capsules
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the safety and effectiveness of treatment with once
      daily oral administration of dexlansoprazole delayed-release capsules in adolescents with
      erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant and parent(s) or legal guardian
             are capable of understanding and complying with protocol requirements.

          2. Prior to any study-specific procedures being performed, the informed consent and the
             assent form, according to local country requirements, must be signed and dated by
             parent(s) or legal guardian and by the participant respectively.

          3. The participant has a medical history of symptoms of Gastroesophageal Reflux Disease
             (GERD) for at least 3 months prior to Screening (signed informed consent form and
             assent, if applicable) as assessed by the investigator.

          4. The participant has met the electronic diary qualification criteria as assessed by the
             electronic daily diary defined as follows: heartburn (burning or hurting in your
             throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within
             1 week of signing informed consent and assent is used to confirm diagnosis of EE, the
             subject does not need to meet this criterion).

          5. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening
             endoscopy.

          6. The participant is male or female and aged 12 to 17 years, inclusive.

          7. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent and assent throughout the duration of the study and for 30 days after last
             dose of study medication.

          8. A female participant of childbearing potential who is or may become sexually active
             agrees to routinely use adequate contraception from the time of signing the informed
             consent and assent until 30 days after the last dose of study medication.

        Exclusion Criteria:

          1. Participant has evidence of cardiovascular, pulmonary, central nervous system,
             hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or
             serious allergy, asthma, or allergic skin rash that suggests clinically significant,
             uncontrolled 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. The participant has a co-existing 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. The participant has known history of Barrett's with dysplastic changes in the
             esophagus.

          4. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic
             findings suggestive of EoE.

          5. The participant has a history of celiac disease or participant tests positive for
             tissue transglutaminase (tTG) antibody.

          6. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

          7. Participant has any finding 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.

          8. Participant has taken any proton pump inhibitor (PPI) within 1 week (7 days) prior to
             the Screening Visit.

          9. Participant tests positive for H. pylori.

         10. The participant has a history of hypersensitivity or allergies to dexlansoprazole or
             any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole,
             rabeprazole, pantoprazole, or esomeprazole) or antacid containing Mg(OH)2 and/or
             Al(OH)3 or simethicone.

         11. The participant is required to take excluded medications or it is anticipated that the
             participant will require treatment with at least one of the disallowed concomitant
             medications during the study evaluation period as specified in the Excluded
             Medications and Treatments Section 7.3.

         12. The participant has a history of malignant disease (except basal cell carcinoma)
             within 5 years prior to Screening.

         13. The participant has a condition that may require inpatient surgery during the course
             of the study.

         14. The participant 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.

         15. The participant is known to be human immunodeficiency virus (HIV) positive.

         16. The participant has current or clinical history of Zollinger-Ellison syndrome or other
             hypersecretory condition.

         17. The participant 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.

         18. The participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior to
             endoscopy.

         19. The participant has donated or lost ≥300 mL blood volume, undergone plasmapheresis, or
             has had a transfusion of any blood product within 90 days prior to the first dose of
             study drug.

         20. The participant has a known history of alcohol abuse or illegal drug use within the
             past 12 months prior to the first dose of study drug.

         21. The participant has any Screening Visit 1 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.

         22. If female, the participant is pregnant or lactating or intending to become pregnant
             before, during or within 30 days after last dose of study medication; or intending to
             donate ova during such time period.

         23. If male, the participant intends to donate sperm during the course of this study or
             within 30 days after last dose of study drug.

         24. The participant, participant's Parent(s) or Legal Guardian 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.

         25. The participant or participant's Parent(s) or Legal Guardian, in the opinion of the
             investigator, is unlikely to comply with the protocol requirements or is unsuitable
             for any other reason.

         26. The participant has participated in another clinical study and/or has received any
             investigational compound within 30 days prior to Screening.