Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
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
3 other identifiers
interventional
372
1 country
64
Brief Summary
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Shorter than P25 for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 20, 2013
August 1, 2013
1.3 years
September 16, 2011
August 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
6 weeks
Secondary Outcomes (3)
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
2 weeks
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
Baseline and 6 weeks
Study Arms (2)
TAK-438 20 mg QD
EXPERIMENTALLansoprazole 30 mg QD
ACTIVE COMPARATORInterventions
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Eligibility Criteria
You may qualify if:
- Participants must have endoscopically confirmed duodenal 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)
You may not qualify if:
- Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
- Participants with an Acute Duodenal Mucosal Lesion (ADML) 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 gastric 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (64)
Unknown Facility
Toyota-shi, Aichi-ken, Japan
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Kamagaya-shi, Chiba, Japan
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Kisarazu-shi, Chiba, Japan
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Fukui-shi, Fukui, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Kurume-shi, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Tagawa-shi, Fukuoka, Japan
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Yanagawa-shi, Fukuoka, Japan
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Yukuhashi-shi, Fukuoka, Japan
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Sappori-shi, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Takarazuka-shi, Hyōgo, Japan
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Hitachi-shi, Ibaraki, Japan
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Hitacinaka-shi, Ibaraki, Japan
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Marugame-shi, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kanoya-shi, Kagoshima-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Yashiro-shi, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Nagasaki, Nagasaki, Japan
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Sasebo-shi, Nagasaki, Japan
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Ōita, Oita Prefecture, Japan
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Okayama, Okayama-ken, Japan
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Shimajiri-gun, Okinawa, Japan
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Daito-shi, Osaka, Japan
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Fujiidera-shi, Osaka, Japan
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Hirakata-shi, Osaka, Japan
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Kishiwada-shi, Osaka, Japan
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Osaka, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Suita-shi, Osaka, Japan
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Takatsuki-shi, Osaka, Japan
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Toyonaka-shi, Osaka, Japan
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Saga, Saga-ken, Japan
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Ageo-shi, Saitama, Japan
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Kumagaya-shi, Saitama, Japan
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Tokorozawa-shi, Saitama, Japan
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Ōtsu, Shiga, Japan
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Shizuoka, Shizuoka, Japan
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Ashikaga-shi, Tochigi, Japan
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Otawara-shi, Tochigi, Japan
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Shimotsuga-gun, Tochigi, Japan
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Shimotsuke-shi, Tochigi, Japan
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Tokushima, Tokushima, Japan
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Hachioji-shi, Tokyo, Japan
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Kodaira-shi, Tokyo, Japan
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Kokubunji-shi, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Mitaka-shi, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Wakayama, Wakayama, Japan
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Yamagata, Yamagata, Japan
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Shimonoseki-shi, Yamaguchi, Japan
Unknown Facility
Kofu, Yamanashi, Japan
Related Publications (1)
Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.
PMID: 27891632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Manager
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
August 20, 2013
Record last verified: 2013-08