Erosive Esophagitis Clinical Trial
Official title:
A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE
The main aims of the study are to check the - side effects and effectiveness of Dexlansoprazole in healing erosive esophagitis (EE) - side effects and effectiveness of Dexlansoprazole in maintaining healed EE in children. Participants will take Dexlansoprazole by mouth.
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 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01452776 -
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Recruiting |
NCT05587309 -
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT04124926 -
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01459367 -
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
Completed |
NCT01499368 -
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
|
Phase 3 | |
Not yet recruiting |
NCT04613895 -
Treatment Effect According to Timing of Administration of DWP14012 40 mg
|
N/A | |
Completed |
NCT02456935 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02028663 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 2 | |
Completed |
NCT03006874 -
Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02388724 -
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01865825 -
Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
|
N/A | |
Completed |
NCT02679508 -
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
|
Phase 4 | |
Recruiting |
NCT06391177 -
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily
|
Phase 1 | |
Completed |
NCT05050188 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008
|
Phase 1 | |
Completed |
NCT01874535 -
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
|
Phase 4 | |
Completed |
NCT00206180 -
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
|
Phase 4 | |
Completed |
NCT01642615 -
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
|
Phase 2 | |
Completed |
NCT01630746 -
A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01509261 -
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
|
Phase 3 |