Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
|ClinicalTrials.gov Identifier: NCT01452724|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Duodenal Ulcer||Drug: TAK-438 Drug: Placebo Drug: Lansoprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||372 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
|Experimental: TAK-438 20 mg QD||
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
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-1749
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
- Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [ Time Frame: 6 weeks ]Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
- Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks [ Time Frame: 4 weeks ]
- Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [ Time Frame: 2 weeks ]
- Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer [ Time Frame: Baseline and 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452724
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|Study Director:||Senior Manager||Takeda|