Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01456247
First received: September 16, 2011
Last updated: May 7, 2014
Last verified: May 2014

September 16, 2011
May 7, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
Incidence of treatment-emergent adverse events [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.
Same as current
Complete list of historical versions of study NCT01456247 on ClinicalTrials.gov Archive Site
  • Change from baseline in Laboratory values [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Electrocardiograms [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Vital signs [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Serum gastrin [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Change from baseline in Pepsinogen I and II [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: Yes ]
  • Recurrence rate of gastric or duodenal ulcer [ Time Frame: Up to 80 weeks. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Gastric Ulcers
  • Duodenal Ulcers
  • Drug: TAK-438
    TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
  • Drug: Placebo
    Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
  • Drug: TAK-438
    TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
  • Drug: Lansoprazole
    Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
    Other Name: AG-1749
  • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
  • Experimental: TAK-438 10 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Experimental: TAK-438 20 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Active Comparator: AG-1749 15 mg QD
    Interventions:
    • Drug: Lansoprazole
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
439
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
  2. Participants who have completed the preceding study
  3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

  1. 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
  2. Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
  3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
  4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
  5. 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
  6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  7. Participants with a previous or current history of aspirin-induced asthma
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01456247
TAK-438/OCT-302, U1111-1123-9658, JapicCTI-111616
No
Takeda
Takeda
Not Provided
Study Director: Senior Manager Takeda
Takeda
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP