A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
Primary Purpose
Gastric Ulcer, Duodenal Ulcer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAK-438
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Ulcer focused on measuring Gastric or duodenal ulcer
Eligibility Criteria
Inclusion Criteria:
- Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
- Prior to study commencement, participants who are capable of signing and dating the information/consent form.
- Participants with a chronic disease (ischaemic cardiac disease, ischaemic cerebrovascular disease, etc.) which requires continuous low-dose aspirin oral therapy for prevention of thromboembolism during the treatment period.
Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
- Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
- Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
- Outpatient participants (inpatients for examinations are acceptable).
- Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose.
Exclusion Criteria:
- Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
- Participants who have previously received TAK-438 in a clinical study or as a treatment
- Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
- Participant who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
- Participants with a plan to change the type, dosage or administration of low-dose aspirin.
- Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
- Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
- Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
- Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a history or complication of aspirin asthma
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or aspirin or salicylic acid agents.
- Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
- Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
- Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
- Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
- Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period
- Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured of basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
- Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers [HBs antigen positive or HCV antibody positive]); however, Participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
- Serum creatinine value: higher than 2 mg/dL
- Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
- Total bilirubin: higher than 2.0 × the upper limit of normal
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAK-438 20 mg QD
Arm Description
Outcomes
Primary Outcome Measures
Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568398
Brief Title
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term low-dose aspirin therapy will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Duodenal Ulcer
Keywords
Gastric or duodenal ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAK-438 20 mg QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAK-438
Primary Outcome Measure Information:
Title
Adverse Event
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
Inclusion Criteria:
Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
Prior to study commencement, participants who are capable of signing and dating the information/consent form.
Participants with a chronic disease (ischaemic cardiac disease, ischaemic cerebrovascular disease, etc.) which requires continuous low-dose aspirin oral therapy for prevention of thromboembolism during the treatment period.
Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
Outpatient participants (inpatients for examinations are acceptable).
Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose.
Exclusion Criteria:
Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
Participants who have previously received TAK-438 in a clinical study or as a treatment
Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
Participant who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
Participants with a plan to change the type, dosage or administration of low-dose aspirin.
Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Participants with a history or complication of aspirin asthma
Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or aspirin or salicylic acid agents.
Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period
Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured of basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers [HBs antigen positive or HCV antibody positive]); however, Participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
Serum creatinine value: higher than 2 mg/dL
Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
Total bilirubin: higher than 2.0 × the upper limit of normal
Facility Information:
City
Funabashi-shi
State/Province
Chiba
Country
Japan
City
Noda-shi
State/Province
Chiba
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Annaka-shi
State/Province
Gunma
Country
Japan
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
City
Kitahiroshima-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Yubari-gun
State/Province
Hokkaido
Country
Japan
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
City
Sanuki-shi
State/Province
Kagawa
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
City
Sasebo-shi
State/Province
Nagasaki
Country
Japan
City
Fuchu-shi
State/Province
Tokyo
Country
Japan
City
Katsushika-ku
State/Province
Tokyo
Country
Japan
City
Meguro-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Nakano-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
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