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A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old

Testing Dexlansoprazole for children's nonerosive reflux symptoms.

Recruiting
2-11 years
All
Phase 2

The study is testing a medicine called Dexlansoprazole, which is used to help children aged 2 to 11 with a condition called GERD (Gastroesophageal Reflux Disease). GERD is when stomach acid goes up into the throat, causing a burning feeling. The medicine comes in capsules, and kids will take it once a day for 12 weeks. The study will see how well the medicine works and what side effects might happen. About 70 kids are needed for the study, and they will be split into groups to take different doses of the medicine.

During the study, parents or caregivers will help track any heartburn symptoms in a special diary. The study will last up to 16 weeks, including up to 4 weeks to check if kids can join. Kids will have to visit the clinic several times and have one follow-up phone call after the study. The study is happening in different places around the world.

  • The study lasts up to 16 weeks with clinic visits.
  • Participants will receive Dexlansoprazole once daily.
  • Parents must help track symptoms in an electronic diary.
Study details
    Gastroesophageal Reflux Disease (GERD)

NCT02616302

Takeda

24 November 2024

Step 1 Get in touch with the nearest study center
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