Erosive Esophagitis Clinical Trial
Official title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo
The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
tested to treat people who have EE. This study will look at erosive esophageal healing in
people who take dexlansoprazole.
The study will enroll approximately 450 participants. Participants will be randomly assigned
to one of the two treatment groups with 1:1 ratio—which will remain undisclosed to the
participant and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 60 mg
- Lansoprazole 30 mg
After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If
the EE is healed participants will be randomly assigned to one of two different treatment
groups with 1:1 ratio:
- Dexlansoprazole 30 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
no active ingredient.
All participants will be asked to take one capsule at the same time each day throughout the
study.
This multi-center trial will be conducted in China. The overall time to participate in this
study is up to 39 weeks. Participants will make 7 visits to the clinic, and will be contacted
by telephone 5 to 10 days 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 | |
| Recruiting |
NCT02615184 -
A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children
|
Phase 2 | |
| 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 |