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

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
- Participants who have completed the preceding study
- Outpatient (including inpatient for examinations)
Exclusion Criteria:
- 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
- Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
- Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
- Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
- 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
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a previous or current history of aspirin-induced asthma

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

Study Director: | Senior Manager | Takeda |
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 |