- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452711
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer
June 19, 2013 updated by: Takeda
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.
The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
482
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aichi
-
Toyota-shi, Aichi, Japan
-
-
Chiba
-
Kamagaya-shi, Chiba, Japan
-
Kisarazu-shi, Chiba, Japan
-
-
Fukui
-
Fukui-shi, Fukui, Japan
-
-
Fukuoka
-
Fukuoka-shi, Fukuoka, Japan
-
Kitakyushu-shi, Fukuoka, Japan
-
Kurume-shi, Fukuoka, Japan
-
Onga-gun, Fukuoka, Japan
-
Tagawa-shi, Fukuoka, Japan
-
Yanagawa-shi, Fukuoka, Japan
-
Yukuhashi-shi, Fukuoka, Japan
-
-
Hokkaido
-
Sappori-shi, Hokkaido, Japan
-
-
Hyogo
-
Kobe-shi, Hyogo, Japan
-
Nishinomiya-shi, Hyogo, Japan
-
Takarazuka-shi, Hyogo, Japan
-
-
Ibaraki
-
Hitachi-shi, Ibaraki, Japan
-
Hitacinaka-shi, Ibaraki, Japan
-
-
Kagawa
-
Marugame-shi, Kagawa, Japan
-
Takamatsu-shi, Kagawa, Japan
-
-
Kagoshima
-
Kagoshima-shi, Kagoshima, Japan
-
Kanoya-shi, Kagoshima, Japan
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan
-
Yokohama-shi, Kanagawa, Japan
-
-
Kumamoto
-
Kumamoto-shi, Kumamoto, Japan
-
Yashiro-shi, Kumamoto, Japan
-
-
Kyoto
-
Kyoto-shi, Kyoto, Japan
-
-
Nagasaki
-
Nagasaki-shi, Nagasaki, Japan
-
Sasebo-shi, Nagasaki, Japan
-
-
Oita
-
Oita-shi, Oita, Japan
-
-
Okayama
-
Okayama-shi, Okayama, Japan
-
-
Okinawa
-
Shimajiri-gun, Okinawa, Japan
-
-
Osaka
-
Daito-shi, Osaka, Japan
-
Fujiidera-shi, Osaka, Japan
-
Hirakata-shi, Osaka, Japan
-
Kishiwada-shi, Osaka, Japan
-
Osaka-shi, Osaka, Japan
-
Sakai-shi, Osaka, Japan
-
Suita-shi, Osaka, Japan
-
Takatsuki-shi, Osaka, Japan
-
Toyonaka-shi, Osaka, Japan
-
-
Saga
-
Saga-shi, Saga, Japan
-
-
Saitama
-
Ageo-shi, Saitama, Japan
-
Kumagaya-shi, Saitama, Japan
-
Tokorozawa-shi, Saitama, Japan
-
-
Shiga
-
Otsu-shi, Shiga, Japan
-
-
Shizuoka
-
Shizuoka-shi, Shizuoka, Japan
-
-
Tochigi
-
Ashikaga-shi, Tochigi, Japan
-
Otawara-shi, Tochigi, Japan
-
Shimotsuga-gun, Tochigi, Japan
-
Shimotsuke-shi, Tochigi, Japan
-
-
Tokushima
-
Tokushima-shi, Tokushima, Japan
-
-
Tokyo
-
Hachioji-shi, Tokyo, Japan
-
Kodaira-shi, Tokyo, Japan
-
Kokubunji-shi, Tokyo, Japan
-
Meguro-ku, Tokyo, Japan
-
Minato-ku, Tokyo, Japan
-
Mitaka-shi, Tokyo, Japan
-
Ota-ku, Tokyo, Japan
-
Setagaya-ku, Tokyo, Japan
-
Shinagawa-ku, Tokyo, Japan
-
-
Wakayama
-
Wakayama-shi, Wakayama, Japan
-
-
Yamagata
-
Yamagata-shi, Yamagata, Japan
-
-
Yamaguchi
-
Shimonoseki-shi, Yamaguchi, Japan
-
-
Yamanashi
-
Kofu-shi, Yamanashi, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must have endoscopically confirmed gastric ulcers (mucosal defect with white coating) At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1)
- Outpatient (including short inpatient for examination and others)
Exclusion Criteria:
- Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
- Participants with an Acute Gastric Mucosal Lesion (AGML) on endoscopy at baseline (Visit 1)
- Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
- Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
- Participants with a duodenal ulcer on endoscopy at baseline (Visit 1)
- Participants with an ulcer for which medical treatment is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
- Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAK-438 20 mg QD
|
TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
TAK-438 placebo-matching tablets, 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 Names:
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks
Time Frame: 4 weeks
|
4 weeks
|
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Time Frame: 2 weeks
|
2 weeks
|
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Gastric Ulcer
Time Frame: Baseline and 8 weeks
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
September 16, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 17, 2011
Study Record Updates
Last Update Posted (Estimate)
June 21, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Ulcer
- Stomach Ulcer
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- TAK-438/CCT-101
- U1111-1123-8551 (Registry Identifier: WHO)
- JapicCTI-111612 (Registry Identifier: JapicCTI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Ulcer
-
Changhai HospitalPeking Union Medical College Hospital; Chinese PLA General Hospital; RenJi Hospital and other collaboratorsCompletedChronic Gastritis | Gastric Diseases, | Gastric Ulcer, | Gastric Polyps, | Early Gastric Cancer,China
-
TakedaCompletedGastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions
-
The Catholic University of KoreaSt Vincent's Hospital; Bucheon St. Mary's HospitalUnknown
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownBleeding Gastric Ulcer | Bleeding Duodenal UlcerChina
-
TakedaCompleted
-
TakedaCompletedGastric Ulcers | Duodenal UlcersJapan
-
TakedaCompletedGastric Ulcers | Duodenal UlcersJapan
-
TakedaCompletedGastric Ulcers | Duodenal UlcersJapan
-
Chuncheon Sacred Heart HospitalCompletedGastric Ulcer Associated With Helicobacter PyloriKorea, Republic of
-
Nanfang Hospital of Southern Medical UniversityUnknown
Clinical Trials on Lansoprazole
-
Charles Mel Wilcox, MDTakeda Pharmaceuticals North America, Inc.CompletedZollinger-Ellison Syndrome | Multiple Endocrine Neoplasia
-
Vanderbilt UniversityTAP Pharmaceutical Products Inc.Completed
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingPeptic UlcerKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.UnknownHealed Erosive EsophagitisKorea, Republic of
-
Emory UniversityUnknown
-
Il-Yang Pharm. Co., Ltd.Not yet recruitingPeptic UlcerKorea, Republic of
-
Onconic Therapeutics Inc.Not yet recruiting
-
Jordan Collaborating Cardiology GroupUniversity of JordanCompleted
-
University of UtahTerminated
-
University of Southern CaliforniaCompletedPeptic Ulcer HemorrhageUnited States