A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy
Study Details
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 NSAID therapy will be investigated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAK-438 20 mg QD
|
Drug: TAK-438
|
Outcome Measures
Primary Outcome Measures
- Adverse Event [24 weeks]
Eligibility Criteria
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 (rheumatoid arthritis, osteoarthritis, etc.) which requires continuous NSAID oral therapy for pain control during 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
-
Participants 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 NSAID
-
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 NSAIDs
-
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 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 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Funabashi-shi | Chiba | Japan | ||
| 2 | Noda-shi | Chiba | Japan | ||
| 3 | Fukuoka-shi | Fukuoka | Japan | ||
| 4 | Annaka-shi | Gunma | Japan | ||
| 5 | Hiroshima-shi | Hiroshima | Japan | ||
| 6 | Hakodate-shi | Hokkaido | Japan | ||
| 7 | Kitahiroshima-shi | Hokkaido | Japan | ||
| 8 | Sapporo-shi | Hokkaido | Japan | ||
| 9 | Yubari-gun | Hokkaido | Japan | ||
| 10 | Kanazawa-shi | Ishikawa | Japan | ||
| 11 | Sanuki-shi | Kagawa | Japan | ||
| 12 | Yashiro-shi | Kumamoto | Japan | ||
| 13 | Nagasaki-shi | Nagasaki | Japan | ||
| 14 | Sasebo-shi | Nagasaki | Japan | ||
| 15 | Fuchu-shi | Tokyo | Japan | ||
| 16 | Katsushika-ku | Tokyo | Japan | ||
| 17 | Meguro-ku | Tokyo | Japan | ||
| 18 | Nakano-ku | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-438/OCT-303
- U1111-1128-5905
- JapicCTI-121789