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CompletedNCT01452698Updated Nov 9, 2012

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

A Phase 3 interventional study of TAK-438 and Placebo in Erosive Esophagitis, sponsored by Takeda. Completed at 32 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
409
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.

02

Conditions studied

  • Erosive Esophagitis

Keywords

  • Drug Therapy
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
  2. Outpatient (including inpatient for examination)

Exclusion criteria

Exclusion Criteria:

  1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
  2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
  3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit 1 (start of the observation period). However, participants with gastric or duodenal erosions are allowed to be included.
  4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
05

Study design

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

Study arms

  • Experimental
    TAK-438 20 mg QD

    Drug: TAK-438 · Drug: Placebo

  • Active comparator
    AG-1749 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. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.

    Also known as: AG-1749

  • DrugLansoprazole

    Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 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 Over 8 Weeks of Erosive Esophagitis

    Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).

    Time frame: 8 Weeks

Secondary outcomes

  1. Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis

    Time frame: 2 Weeks

  2. Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

    Time frame: 4 Weeks

07

Study locations

32 sites
  • Nagoya, Aichi-ken, Japan
  • Abiko-shi, Chiba, Japan
  • Fukuoka, Fukuoka, Japan
  • Itoshima-shi, Fukuoka, Japan
  • Kurume-shi, Fukuoka, Japan
  • Onga-gun, Fukuoka, Japan
  • Gifu, Gifu, Japan
  • Annaka-shi, Gunma, Japan
  • Aki-gun, Hiroshima, Japan
  • Hiroshima, Hiroshima, Japan
  • Sapporo, Hokkaido, Japan
  • Amagasaki-shi, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Takarazuka-shi, Hyōgo, Japan
  • Sakade-shi, Kagawa-ken, Japan
  • Yokohama, Kanagawa, Japan
  • Kochi, Kochi, Japan
  • Susaki-shi, Kochi, Japan
  • Kumamoto, Kumamoto, Japan
  • Kyoto, Kyoto, Japan
  • Nagasaki, Nagasaki, Japan
  • Ōita, Oita Prefecture, Japan
  • Okayama, Okayama-ken, Japan
  • Fuziidera-shi, Osaka, Japan
  • Shizuoka, Shizuoka, Japan
  • Otawara-shi, Tochigi, Japan
  • Chiyoda-ku, Tokyo, Japan
  • Chuo-ku, Tokyo, Japan
  • Nakano-ku, Tokyo, Japan
  • Ōta-ku, Tokyo, Japan
  • Setagaya-ku, Tokyo, Japan
  • Yamagata, Yamagata, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01452698
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Oct 17, 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Nov 9, 2012

Study contacts

Senior Manager
study director · Takeda

Oversight

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

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