Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452724
Show 64 Study Locations
|Study Director:||Senior Manager||Takeda|