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

Duodenal Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456247
• Other study ID #: TAK-438/OCT-302
• Secondary ID: U1111-1123-9658J
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2011
• Last updated: May 7, 2014
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Duodenal Ulcer
• Duodenal Ulcers
• Gastric Ulcers
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• TAK-438
TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
• Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
• TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
• Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
• Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
• Placebo
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	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.	Up to 80 weeks.	Yes
Secondary	Change from baseline in Laboratory values		Up to 80 weeks.	Yes
Secondary	Change from baseline in Electrocardiograms		Up to 80 weeks.	Yes
Secondary	Change from baseline in Vital signs		Up to 80 weeks.	Yes
Secondary	Change from baseline in Serum gastrin		Up to 80 weeks.	Yes
Secondary	Change from baseline in Pepsinogen I and II		Up to 80 weeks.	Yes
Secondary	Recurrence rate of gastric or duodenal ulcer		Up to 80 weeks.	No