Efficacy and Safety 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, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety 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: NCT01452763
• Other study ID #: TAK-438/CCT-302
• Secondary ID: U1111-1123-8746J
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2011
• Last updated: January 17, 2014
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: January 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 efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) 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: 621
• Est. completion date: April 2013
• Est. primary completion date: April 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 a history of ulcer in stomach or duodenum, endoscopically confirmed

3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants scheduled to change the type and dosage regimen of low-dose aspirin

2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed

3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology

4. 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

5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders

6. 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 up to 24 weeks.
• Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
• TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
• Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
• Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
• Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 24 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	Recurrence rate of gastric or duodenal ulcer within 24 weeks	Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.	24 weeks	No
Secondary	Recurrence rate of gastric or duodenal ulcer within 12 weeks		12 weeks	No
Secondary	Gastric mucosal injury		24 Weeks	No
Secondary	Duodenal mucosal injury		24 weeks	No
Secondary	Occurrence rate of hemorrhagic lesion in stomach or duodenum		24 weeks	No
Secondary	Time to recurrence of gastric or duodenal ulcer		24 weeks	No