Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
NCT ID: NCT01459367
Last Updated: 2013-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
607 participants
INTERVENTIONAL
2011-10-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAK-438 10 mg QD
TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
TAK-438 20 mg QD
TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole 15 mg QD
Lansoprazole
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Outpatients (including inpatient for examination)
3. Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.
Exclusion Criteria
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit H-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Senior Manager
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kashiwa-shi, Chiba, Japan
Yachiyo-shi, Chiba, Japan
Saijo-shi, Ehime, Japan
Fukuoka, Fukuoka, Japan
Kasuya-gun, Fukuoka, Japan
Koriyama-shi, Fukushima, Japan
Takayama-shi, Gifu, Japan
Annaka-shi, Gunma, Japan
Asahikawa-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Itami-shi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya-shi, Hyōgo, Japan
Fujisawa-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Nagasaki, Nagasaki, Japan
Kishiwada-shi, Osaka, Japan
Osaka, Osaka, Japan
Suita-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Saga, Saga-ken, Japan
Kumagaya-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Hachioji-shi, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Shimonoseki-shi, Yamaguchi, Japan
Tsuru-shi, Yamanashi, Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1125-1054
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111662
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/CCT-003
Identifier Type: -
Identifier Source: org_study_id