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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

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
  Purpose
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 Intervention Phase
Gastric Ulcers Duodenal Ulcers Drug: TAK-438 Drug: Placebo Drug: Lansoprazole Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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:
  • Change from baseline in Laboratory values [ Time Frame: Up to 80 weeks. ]
  • Change from baseline in Electrocardiograms [ Time Frame: Up to 80 weeks. ]
  • Change from baseline in Vital signs [ Time Frame: Up to 80 weeks. ]
  • Change from baseline in Serum gastrin [ Time Frame: Up to 80 weeks. ]
  • Change from baseline in Pepsinogen I and II [ Time Frame: Up to 80 weeks. ]
  • Recurrence rate of gastric or duodenal ulcer [ Time Frame: Up to 80 weeks. ]

Enrollment: 439
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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: NCT01456247

  Show 76 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

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 )
Study First Received: September 16, 2011
Last Updated: May 7, 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

ClinicalTrials.gov processed this record on September 19, 2017