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Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Ulcer

Intervention: TAK-438 (Drug); Placebo (Drug); Lansoprazole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Senior Manager, Study Director, Affiliation: Takeda

Summary

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks

Secondary outcome:

Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks

Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2

Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Gastric Ulcer

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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) 2. Outpatient (including short inpatient for examination and others) Exclusion Criteria: 1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1) 2. Participants with an Acute Gastric Mucosal Lesion (AGML) 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 duodenal 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)

Locations and Contacts

Toyota-shi, Aichi, Japan

Kamagaya-shi, Chiba, Japan

Kisarazu-shi, Chiba, Japan

Fukui-shi, Fukui, Japan

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

Sappori-shi, Hokkaido, Japan

Kobe-shi, Hyogo, Japan

Nishinomiya-shi, Hyogo, Japan

Takarazuka-shi, Hyogo, Japan

Hitachi-shi, Ibaraki, Japan

Hitacinaka-shi, Ibaraki, Japan

Marugame-shi, Kagawa, Japan

Takamatsu-shi, Kagawa, Japan

Kagoshima-shi, Kagoshima, Japan

Kanoya-shi, Kagoshima, Japan

Kawasaki-shi, Kanagawa, Japan

Yokohama-shi, Kanagawa, Japan

Kumamoto-shi, Kumamoto, Japan

Yashiro-shi, Kumamoto, Japan

Kyoto-shi, Kyoto, Japan

Nagasaki-shi, Nagasaki, Japan

Sasebo-shi, Nagasaki, Japan

Oita-shi, Oita, Japan

Okayama-shi, Okayama, Japan

Shimajiri-gun, Okinawa, Japan

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-shi, Saga, Japan

Ageo-shi, Saitama, Japan

Kumagaya-shi, Saitama, Japan

Tokorozawa-shi, Saitama, Japan

Otsu-shi, Shiga, Japan

Shizuoka-shi, Shizuoka, Japan

Ashikaga-shi, Tochigi, Japan

Otawara-shi, Tochigi, Japan

Shimotsuga-gun, Tochigi, Japan

Shimotsuke-shi, Tochigi, Japan

Tokushima-shi, 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

Ota-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Wakayama-shi, Wakayama, Japan

Yamagata-shi, Yamagata, Japan

Shimonoseki-shi, Yamaguchi, Japan

Kofu-shi, Yamanashi, Japan

Additional Information

Starting date: November 2011
Last updated: June 19, 2013

Page last updated: August 23, 2015

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