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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 if Dexlansoprazole is safe for kids with reflux symptoms.

Recruiting
2-11 years
All
Phase 2

**Gastroesophageal reflux disease (GERD)** is when food or stomach acid comes up into the esophagus, the tube carrying food from the mouth to the stomach. **Nonerosive GERD** is when you have GERD symptoms but without damage to the esophagus. Symptoms include heartburn, pain, and trouble eating. This study tests **dexlansoprazole**, a medicine that may help with GERD symptoms in children aged 2 to 11.

The study will involve about 70 children. Based on their weight, participants will get different doses of dexlansoprazole. Kids weighing 30 kilograms (about 66 pounds) or less will receive either 15 or 30 milligrams (mg). Those over 30 kg will receive 30 or 60 mg. They will take one pill daily.

  • **Duration**: 16 weeks total, including a 4-week screening period.
  • **Participation**: Multiple clinic visits and a follow-up phone call.
  • **Eligibility**: Children aged 2-11 with GERD symptoms for at least 3 months.

Parents need to record their child's symptoms in a diary. The study checks dexlansoprazole's safety and how well it works. It's important to consult your doctor to understand if this study is suitable for your child.

Study details
    Gastroesophageal Reflux Disease (GERD)

NCT02616302

Takeda

24 November 2024

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