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

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ClinicalTrials.gov Identifier: NCT01456247
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Ulcers Duodenal Ulcers Drug: TAK-438 Drug: Placebo Drug: Lansoprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TAK-438 10 mg QD 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.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.

Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Active Comparator: AG-1749 15 mg QD 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Up to 80 weeks. ]
    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.


Secondary Outcome Measures :
  1. Change from baseline in Laboratory values [ Time Frame: Up to 80 weeks. ]
  2. Change from baseline in Electrocardiograms [ Time Frame: Up to 80 weeks. ]
  3. Change from baseline in Vital signs [ Time Frame: Up to 80 weeks. ]
  4. Change from baseline in Serum gastrin [ Time Frame: Up to 80 weeks. ]
  5. Change from baseline in Pepsinogen I and II [ Time Frame: Up to 80 weeks. ]
  6. Recurrence rate of gastric or duodenal ulcer [ Time Frame: Up to 80 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456247


  Show 76 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01456247     History of Changes
Other Study ID Numbers: TAK-438/OCT-302
U1111-1123-9658 ( Registry Identifier: WHO )
JapicCTI-111616 ( Registry Identifier: JapicCTI )
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Aspirin
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents