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CompletedNCT01452711Updated Jun 21, 2013

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

A Phase 3 interventional study of TAK-438 and Placebo in Gastric Ulcer, sponsored by Takeda. Completed at 64 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
482
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Ulcer

Keywords

  • Drug Therapy
03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 482 is above the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
482 participants (actual)

Study arms

  • Experimental
    TAK-438 20 mg QD

    Drug: TAK-438 · Drug: Placebo

  • Active comparator
    Lansoprazole 30 mg QD

    Drug: Lansoprazole · Drug: Placebo

Interventions

  • DrugTAK-438

    TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

  • DrugPlacebo

    Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.

  • DrugLansoprazole

    Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

    Also known as: AG-1749

  • DrugPlacebo

    TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

06

What researchers measure

Primary outcomes

  1. Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks

    Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

    Time frame: 8 weeks

Secondary outcomes

  1. Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks

    Time frame: 4 weeks

  2. Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2

    Time frame: 2 weeks

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

    Time frame: Baseline and 8 weeks

07

Study locations

64 sites
  • 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
08

References and documents

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. PubMed 27891632 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01452711
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Oct 17, 2011
Start date
Nov 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jun 21, 2013

Study contacts

Senior Manager
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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