A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01568398
First received: March 29, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Gastric Ulcer
Duodenal Ulcer
Drug: TAK-438
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-438 20 mg QD Drug: TAK-438

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
  2. Prior to study commencement, participants who are capable of signing and dating the information/consent form.
  3. 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.
  4. 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).
  5. Outpatient participants (inpatients for examinations are acceptable).
  6. 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:

  1. Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
  2. Participants who have previously received TAK-438 in a clinical study or as a treatment
  3. 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
  4. Participant who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
  5. Participants with a plan to change the type, dosage or administration of low-dose aspirin.
  6. 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)
  7. Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
  8. Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
  9. Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  10. Participants with a history or complication of aspirin asthma
  11. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or aspirin or salicylic acid agents.
  12. 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
  13. Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
  14. 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
  15. 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
  16. Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period
  17. 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.
  18. 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.
  19. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568398

Locations
Japan
Funabashi-shi, Chiba, Japan
Noda-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Annaka-shi, Gunma, Japan
Hiroshima-shi, Hiroshima, Japan
Hakodate-shi, Hokkaido, Japan
Kitahiroshima-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Yubari-gun, Hokkaido, Japan
Kanazawa-shi, Ishikawa, Japan
Sanuki-shi, Kagawa, Japan
Sendai-shi, Miyagi, Japan
Nagasaki-shi, Nagasaki, Japan
Sasebo-shi, Nagasaki, Japan
Fuchu-shi, Tokyo, Japan
Katsushika-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01568398     History of Changes
Other Study ID Numbers: TAK-438/OCT-304, U1111-1128-6012, JapicCTI-121790
Study First Received: March 29, 2012
Last Updated: February 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Gastric or duodenal ulcer

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 30, 2014