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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 19 | — | — | Jul 1, 2012 | Sep 1, 2013 | Feb 10, 2014 | 11 | Japan |
| NCT01459367 | Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis | PHASE3 | COMPLETED | 607 | — | — | Oct 1, 2011 | Mar 1, 2013 | Aug 23, 2013 | 37 | Japan |
| NCT01452776 | Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis | PHASE3 | COMPLETED | 305 | — | — | Sep 1, 2011 | Jul 1, 2013 | Nov 5, 2013 | 32 | Japan |
| NCT01452698 | Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis | PHASE3 | COMPLETED | 409 | — | — | - | Aug 1, 2012 | Nov 9, 2012 | 32 | Japan |
Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.
Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
| Arm | Type | Description |
|---|---|---|
| TAK-438 20 mg/day | EXPERIMENTAL | - |
| TAK-438 40 mg/day | EXPERIMENTAL | - |
| TAK-438 10 mg QD | EXPERIMENTAL | - |
| TAK-438 20 mg QD | EXPERIMENTAL | - |
| Lansoprazole 15 mg QD | ACTIVE_COMPARATOR | - |
| AG-1749 30 mg QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-438 | DRUG | - |
| Lansoprazole | DRUG | In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks. |
| Placebo | DRUG | Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. |
Inclusion Criteria: 1. The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase. 2. Outpatient (in principle) 3. At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscop...