18 and older, any sex, with Erosive Esophagitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Healing Period: Percentage of Participants With Complete Healing of EE at Week 8Primary· Week 8
Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (\>=1 mucosal break no longer than 5 millimeter \[mm\] that does not extend between the tops of 2 mucosal folds); Grade B (\>=1 mucosal break greater than \[\>\] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (\>=1 mucosal break that is continuous between the tops o
Group
Value
95% CI
Healing Period: Lansoprazole 30 mg
85.0
Healing Period: Dexlansoprazole 60 mg
82.4
Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6Secondary· Month 6
Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (\>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (\>=1 mucosal break \>5 mm that does not extend between the tops of 2 mucosal folds); Grade C (\>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves \<75% o
Group
Value
95% CI
Maintenance Period: Placebo
0
Maintenance Period: Dexlansoprazole 30 mg
25
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 5 to 10 days (Day 190) after the last dose of double-blind study drug..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT02442752 — Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
· Phase 1
· withdrawn
NCT02615184 — A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in C
· Phase 2
· active not recruiting
NCT02616302 — A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux
· Phase 2
· recruiting
NCT04877834 — Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Heal
· Phase 1
· completed
NCT03316976 — A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Heal
· Phase 1
· completed
Other recruiting trials for Erosive Esophagitis
Currently open trials in the same condition.
NCT02615184 — A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in C
· Phase 2
· active not recruiting
NCT05267613 — Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
· Phase 3
· recruiting
NCT04255693 — Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
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· recruiting
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 22 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02873702.