Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
NCT ID: NCT01452724
Last Updated: 2013-08-20
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
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COMPLETED
PHASE3
372 participants
INTERVENTIONAL
2011-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAK-438 20 mg QD
TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
Lansoprazole 30 mg QD
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
Interventions
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TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Outpatient (including short inpatient for examination and others)
Exclusion Criteria
2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
20 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Manager
Role: STUDY_DIRECTOR
Takeda
Locations
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Toyota-shi, Aichi-ken, Japan
Kamagaya-shi, Chiba, Japan
Kisarazu-shi, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukuoka, 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
Sappori-shi, Hokkaido, Japan
Kobe, Hyōgo, Japan
Nishinomiya-shi, Hyōgo, Japan
Takarazuka-shi, Hyōgo, Japan
Hitachi-shi, Ibaraki, Japan
Hitacinaka-shi, Ibaraki, Japan
Marugame-shi, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kanoya-shi, Kagoshima-ken, Japan
Kawasaki-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Yashiro-shi, Kumamoto, Japan
Kyoto, Kyoto, Japan
Nagasaki, Nagasaki, Japan
Sasebo-shi, Nagasaki, Japan
Ōita, Oita Prefecture, Japan
Okayama, Okayama-ken, Japan
Shimajiri-gun, Okinawa, Japan
Daito-shi, Osaka, Japan
Fujiidera-shi, Osaka, Japan
Hirakata-shi, Osaka, Japan
Kishiwada-shi, Osaka, Japan
Osaka, Osaka, Japan
Sakai-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Toyonaka-shi, Osaka, Japan
Saga, Saga-ken, Japan
Ageo-shi, Saitama, Japan
Kumagaya-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Ōtsu, Shiga, Japan
Shizuoka, Shizuoka, Japan
Ashikaga-shi, Tochigi, Japan
Otawara-shi, Tochigi, Japan
Shimotsuga-gun, Tochigi, Japan
Shimotsuke-shi, Tochigi, Japan
Tokushima, Tokushima, Japan
Hachioji-shi, Tokyo, Japan
Kodaira-shi, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Wakayama, Wakayama, Japan
Yamagata, Yamagata, Japan
Shimonoseki-shi, Yamaguchi, Japan
Kofu, Yamanashi, Japan
Countries
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References
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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.
Other Identifiers
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U1111-1123-8648
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111608
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/CCT-102
Identifier Type: -
Identifier Source: org_study_id