Status:
COMPLETED
Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
Lead Sponsor:
Takeda
Conditions:
Gastric Ulcers
Duodenal Ulcers
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric...
Eligibility Criteria
Inclusion
- Participants who require continuous NSAID therapy during the treatment period with the study drug
- Participants who have completed the preceding study
- Outpatient (including inpatient for examinations)
Exclusion
- Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
- Participants who are scheduled to change the type and dosage regimen of NSAID
- Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
- Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
- Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a previous or current history of aspirin-induced asthma
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT01456260
Start Date
September 1 2011
End Date
December 1 2013
Last Update
May 8 2014
Active Locations (97)
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1
Kasugai-shi, Aichi-ken, Japan
2
Nagoya, Aichi-ken, Japan
3
Seto-shi, Aichi-ken, Japan
4
Akita, Akita, Japan