Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

Duodenal Ulcer Clinical Trial

Official title:

A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452724
• Other study ID #: TAK-438/CCT-102
• Secondary ID: U1111-1123-8648J
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2011
• Last updated: August 19, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• 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 determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).

2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)

2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)

3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)

4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)

5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)

6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)

7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)

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

9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Duodenal Ulcer
• Ulcer

Intervention

Drug:
• TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
• Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
• Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
• Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 6 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	Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks	Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.	6 weeks	No
Secondary	Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks		4 weeks	No
Secondary	Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2		2 weeks	No
Secondary	Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer		Baseline and 6 weeks	No