Status:
COMPLETED
Long-Term Safety Study of TAK-438 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 determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
Eligibility Criteria
Inclusion
- Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.\*
- \* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
- Outpatient (including inpatient for examination)
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 M-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 :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT01452776
Start Date
September 1 2011
End Date
July 1 2013
Last Update
November 5 2013
Active Locations (32)
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1
Nagoya, Aichi-ken, Japan
2
Abiko-shi, Chiba, Japan
3
Fukuoka, Fukuoka, Japan
4
Itoshima-shi, Fukuoka, Japan