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. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE). Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of EE in children.
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal EE and maintain healing of EE in pediatric participants aged 2 to 11 years. This study will look at the healing of EE followed by maintained healing of EE in children who take dexlansoprazole. The study will be conducted in two periods; a Healing of EE Period and a Maintenance of Healed EE Period. Approximately 76 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 milligrams (mg) or dexlansoprazole 30 mg for 8 weeks during the Healing of EE Period. Following Week 8, participants will enter the Maintenance of Healed EE Period and will receive half their healing dose of dexlansoprazole, (i.e., either 30 mg, dexlansoprazole 15 mg). All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have heartburn symptoms in a diary. Participants who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24) and have maintained healing of EE as confirmed by endoscopy, will enter a Post-Treatment Follow up Period for up to 3 months after the last dose of study drug. During this period participants will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Participants who require an invasive procedure or treatment with a proton pump inhibitor (PPI) or histamine 2-receptor antagonist (H2RA) for gastroesophageal reflux disease (GERD)/EE will be discontinued from the Post-Treatment Follow-up Period and a Final Study Visit will be performed. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 10 months. Participants will make multiple visits to the clinic including a final visit 3 months after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
Dexlansoprazole capsules
University of South Alabama
Mobile, Alabama, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGD&H National Research Centers
Miami, Florida, United States
RECRUITINGChildren's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Percentage of Participants with Healing of EE by Week 8
Healing of EE will be assessed by endoscopy.
Time frame: Week 8
Percentage of Participants who Maintained Healed EE from Week 8 to Week 24
Percentage of participants who maintained healed EE from Week 8 to Week 24 among the participants who were healed at Week 8 as assessed by endoscopy.
Time frame: Week 8 to Week 24
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 Weeks of Treatment
Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.
Time frame: Week 8
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 Among Participants Who were Healed by Week 8
Daily eDiaries will be completed which contain PGSDD questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.
Time frame: Weeks 8 to 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gastrointestinal Associates, PA
Flowood, Mississippi, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGMeasurable Outcome Research
Oklahoma City, Oklahoma, United States
NOT_YET_RECRUITINGGI for Kids
Knoxville, Tennessee, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
NOT_YET_RECRUITINGEnvision Clinical Research, LLC
Laredo, Texas, United States
RECRUITING...and 15 more locations