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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

Testing dexlansoprazole's safety for healing esophagitis in kids 2-11.

Recruiting
2-11 years
All
Phase 2

This study is about a medicine called dexlansoprazole that helps reduce acid in the stomach. The study is for kids aged 2 to 11 who have erosive esophagitis (EE), which is damage to the tube carrying food from the mouth to the stomach. This can happen because of gastroesophageal reflux disease (GERD), where acid from the stomach causes a burning feeling called heartburn. The study tests if dexlansoprazole can heal and keep EE healed in children, like it does for adults.

Participants will take the medicine in two stages: first for 8 weeks to heal EE, then for 16 weeks to keep it healed. They will take one capsule daily and record any heartburn symptoms. After treatment, there will be a follow-up for up to 3 months. The whole study lasts up to 10 months, with multiple clinic visits.

  • The study lasts up to 10 months with several visits.
  • Participants take daily medicine to test effectiveness.
  • Heartburn symptoms are tracked in a diary.
Study details
    Erosive Esophagitis

NCT02615184

Takeda

10 October 2024

Step 1 Get in touch with the nearest study center
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