A Phase 2, Double-Blind, 12-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease
Takeda
Summary
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.
Description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat children aged 2 to 11 years who have nonerosive GERD. This study will look at the effectiveness and side effects of three different doses of dexlansoprazole in children with GERD. The study will enroll approximately 70 patients. Participants weighing ≤30 kilograms (kg) will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 15 or 30 milligrams (mg), and participants who weigh \>30 kg will be randomized to receive dexlansoprazole 30 or 60 mg. All participants…
Eligibility
- Age range
- 2–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. In the opinion of the investigator, the participant (as age appropriate) and/or parent(s)/legal guardian is capable of understanding and complying with protocol requirements. 2. Prior to any study-specific procedures being performed, the appropriate informed consent and the assent form(s) (as applicable) must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate. 3. Has a medical history of symptoms of GERD for at least 3 months prior to Screening. 4. Has met the eDiary qualification criteria as assessed by the PGSDD, def…
Interventions
- DrugDexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Locations (33)
- Childrens Center for Digestive Health Care, LLCMobile, Alabama
- University of Utah/ Primary Childrens HospitalSan Francisco, California
- Gastrointestinal Associates, PACentennial, Colorado
- Envision Clinical Research, LLCMiami, Florida
- GI For KidsAtlanta, Georgia
- Strada Patient Care Center, Department of Pediatric GastroenterologyChicago, Illinois