Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer
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|ClinicalTrials.gov Identifier: NCT01452711|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastric Ulcer||Drug: TAK-438 Drug: Placebo Drug: Lansoprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||482 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 Gastric Ulcer.|
|Study Start Date :||November 2011|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
|Experimental: TAK-438 20 mg QD||
TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
|Active Comparator: Lansoprazole 30 mg QD||
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Other Name: AG-1749Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
- Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks [ Time Frame: 8 weeks ]Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
- Endoscopic healing Rates of Gastric 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 Gastric Ulcer [ Time Frame: Baseline and 8 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): NCT01452711
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|Study Director:||Senior Manager||Takeda|