Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
NCT ID: NCT01452776
Last Updated: 2013-11-05
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
305 participants
INTERVENTIONAL
2011-09-30
2013-07-31
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
SINGLE
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
TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
TAK-438 20 mg QD
TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAK-438
TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
\* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
2. Outpatient (including inpatient for examination)
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 M-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.
Nagoya, Aichi-ken, Japan
Abiko-shi, Chiba, Japan
Fukuoka, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Gifu, Gifu, Japan
Annaka-shi, Gunma, Japan
Aki-gun, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Amagasaki-shi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Takarazuka-shi, Hyōgo, Japan
Sakaide-shi, Kagawa-ken, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Susaki-shi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Nagasaki, Nagasaki, Japan
Ōita, Oita Prefecture, Japan
Okayama, Okayama-ken, Japan
Fuziidera-shi, Osaka, Japan
Shizuoka, Shizuoka, Japan
Otawara-shi, Tochigi, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Yamagata, Yamagata, 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.
U1111-1123-9677
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111615
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/OCT-001
Identifier Type: -
Identifier Source: org_study_id