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

Phase 3

Completed

• Conditions: Gastric Ulcers; Duodenal Ulcers
• Interventions: Drug: TAK-438; Drug: Lansoprazole; Drug: Placebo

• Registration Number: NCT01456247
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Study Start: 2012-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-438 20 mg QD	Placebo	-
TAK-438 10 mg QD	TAK-438	-
TAK-438 20 mg QD	TAK-438	-
TAK-438 10 mg QD	Placebo	-
AG-1749 15 mg QD	Placebo	-
AG-1749 15 mg QD	Lansoprazole	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	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

Name	Time	Method
Change from baseline in Electrocardiograms	Up to 80 weeks.
Change from baseline in Serum gastrin	Up to 80 weeks.
Change from baseline in Pepsinogen I and II	Up to 80 weeks.
Change from baseline in Laboratory values	Up to 80 weeks.
Change from baseline in Vital signs	Up to 80 weeks.
Recurrence rate of gastric or duodenal ulcer	Up to 80 weeks.