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

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

Study Overview

• Status: Completed
• Conditions: Duodenal Ulcer
• Intervention / Treatment: Drug: TAK-438; Drug: Placebo; Drug: Placebo; Drug: Lansoprazole

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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

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:

1. 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).
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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAK-438 20 mg QD	Drug: TAK-438; TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.; Drug: Placebo; Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.; Drug: Placebo; TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
ACTIVE_COMPARATOR: Lansoprazole 30 mg QD	Drug: Placebo; Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.; Drug: Placebo; TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.; Drug: Lansoprazole; Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.; Other Names: AG-1749

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2	2 weeks
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks	4 weeks
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

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): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Duodenal 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-102; U1111-1123-8648 (REGISTRY: WHO); JapicCTI-111608 (REGISTRY: JapicCTI)