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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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:

Drug Information available for: Aspirin Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]


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)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

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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 JapicCTI-111616
Study First Received:	September 16, 2011
Last Updated:	May 7, 2014
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 28, 2016