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

Inclusion criteria

• ✓. In the opinion of the investigator, the participant and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
• ✓. 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.
• ✓. 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.
• ✓. 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).
• ✓. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening endoscopy.
• ✓. The participant is male or female and aged 12 to 17 years, inclusive.
• ✓. 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.
• ✓. 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