Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
This study has been completed.
Information provided by (Responsible Party):
First received: September 16, 2011
Last updated: August 19, 2013
Last verified: August 2013
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Takeda:
Primary Outcome Measures:
- Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
Secondary Outcome Measures:
- Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: TAK-438 20 mg QD||
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
|Active Comparator: Lansoprazole 30 mg QD||
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Other Name: AG-1749Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452724
Show 64 Study Locations
Show 64 Study Locations
Sponsors and Collaborators
|Study Director:||Senior Manager||Takeda|