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

August 22, 2013 updated by: Takeda

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE).

The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

607

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan
      • Yachiyo-shi, Chiba, Japan
    • Ehime
      • Saijo-shi, Ehime, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kasuya-gun, Fukuoka, Japan
    • Fukushima
      • Koriyama-shi, Fukushima, Japan
    • Gifu
      • Takayama-shi, Gifu, Japan
    • Gunma
      • Annaka-shi, Gunma, Japan
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Hyogo
      • Itami-shi, Hyogo, Japan
      • Kobe-shi, Hyogo, Japan
      • Nishinomiya-shi, Hyogo, Japan
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan
      • Yokohama-shi, Kanagawa, Japan
    • Kochi
      • Kochi-shi, Kochi, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
    • Miyagi
      • Sendai-shi, Miyagi, Japan
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan
    • Osaka
      • Kishiwada-shi, Osaka, Japan
      • Osaka-shi, Osaka, Japan
      • Suita-shi, Osaka, Japan
      • Takatsuki-shi, Osaka, Japan
    • Saga
      • Saga-shi, Saga, Japan
    • Saitama
      • Kumagaya-shi, Saitama, Japan
      • Saitama-shi, Saitama, Japan
      • Tokorozawa-shi, Saitama, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Chuo-ku, Tokyo, Japan
      • Hachioji-shi, Tokyo, Japan
      • Kokubunji-shi, Tokyo, Japan
      • Shibuya-ku, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan
      • Toshima-ku, Tokyo, Japan
    • Yamaguchi
      • Shimonoseki-shi, Yamaguchi, Japan
    • Yamanashi
      • Tsuru-shi, Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At Visit H-1 (start of the treatment period), the participants 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 15% or more of the total participants.
  2. Outpatients (including inpatient for examination)
  3. Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.

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 H-1 (initiation of study drug administration). 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 disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAK-438 10 mg QD
Drug: TAK-438

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

Drug: TAK-438

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Experimental: TAK-438 20 mg QD
Drug: TAK-438

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

Drug: TAK-438

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Active Comparator: Lansoprazole 15 mg QD
Drug: Lansoprazole

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.

Other Names:
  • AG-1749

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment
Time Frame: 24 Weeks.
Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D 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).
24 Weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment
Time Frame: 12 Weeks.
12 Weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-438/CCT-003
  • U1111-1125-1054 (Registry Identifier: WHO)
  • JapicCTI-111662 (Registry Identifier: JapicCTI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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