Status:
COMPLETED
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
Lead Sponsor:
Takeda
Conditions:
Erosive Esophagitis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dos...
Eligibility Criteria
Inclusion
- At Visit H-1 (start of the treatment period), the participants must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 15% or more of the total participants.
- Outpatients (including inpatient for examination)
- Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.
Exclusion
- Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit H-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT01459367
Start Date
October 1 2011
End Date
March 1 2013
Last Update
August 23 2013
Active Locations (37)
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1
Kashiwa-shi, Chiba, Japan
2
Yachiyo-shi, Chiba, Japan
3
Saijo-shi, Ehime, Japan
4
Fukuoka, Fukuoka, Japan