Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00321737 | Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis | PHASE3 | COMPLETED | 445 | — | — | May 1, 2006 | May 1, 2007 | Feb 3, 2012 | 98 | United States, Australia +6 |
| NCT00255151 | Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis | PHASE3 | COMPLETED | 451 | — | — | Jan 1, 2006 | Nov 1, 2006 | Feb 3, 2012 | 100 | United States |
| NCT00255164 | Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis | PHASE3 | COMPLETED | 451 | — | — | Jan 1, 2006 | Nov 1, 2006 | Feb 3, 2012 | 96 | United States |
| NCT00251693 | Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis | PHASE3 | COMPLETED | 2,038 | — | — | Dec 1, 2005 | Jan 1, 2007 | Feb 3, 2012 | 140 | United States, Australia +13 |
| NCT00251719 | Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis | PHASE3 | COMPLETED | 2,054 | — | — | Dec 1, 2005 | Jan 1, 2007 | Feb 3, 2012 | 144 | United States, Australia +14 |
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
| Arm | Type | Description |
|---|---|---|
| Dexlansoprazole MR 30 mg QD | EXPERIMENTAL | - |
| Dexlansoprazole MR 60 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Dexlansoprazole MR 90 mg QD | EXPERIMENTAL | - |
| Lansoprazole 30 mg QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dexlansoprazole MR | DRUG | Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months. |
| Placebo | DRUG | Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months. |
| Lansoprazole | DRUG | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. |
Inclusion Criteria: * Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (...