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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01459367
Collaborator
(none)
607
Enrollment
37
Locations
3
Arms
17
Duration (Months)
16.4
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
607 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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).
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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.
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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment [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).

    Secondary Outcome Measures

    1. Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment [12 Weeks.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kashiwa-shi Chiba Japan
    2 Yachiyo-shi Chiba Japan
    3 Saijo-shi Ehime Japan
    4 Fukuoka-shi Fukuoka Japan
    5 Kasuya-gun Fukuoka Japan
    6 Koriyama-shi Fukushima Japan
    7 Takayama-shi Gifu Japan
    8 Annaka-shi Gunma Japan
    9 Asahikawa-shi Hokkaido Japan
    10 Sapporo-shi Hokkaido Japan
    11 Itami-shi Hyogo Japan
    12 Kobe-shi Hyogo Japan
    13 Nishinomiya-shi Hyogo Japan
    14 Fujisawa-shi Kanagawa Japan
    15 Yokohama-shi Kanagawa Japan
    16 Kochi-shi Kochi Japan
    17 Kumamoto-shi Kumamoto Japan
    18 Kyoto-shi Kyoto Japan
    19 Sendai-shi Miyagi Japan
    20 Nagasaki-shi Nagasaki Japan
    21 Kishiwada-shi Osaka Japan
    22 Osaka-shi Osaka Japan
    23 Suita-shi Osaka Japan
    24 Takatsuki-shi Osaka Japan
    25 Saga-shi Saga Japan
    26 Kumagaya-shi Saitama Japan
    27 Saitama-shi Saitama Japan
    28 Tokorozawa-shi Saitama Japan
    29 Bunkyo-ku Tokyo Japan
    30 Chuo-ku Tokyo Japan
    31 Hachioji-shi Tokyo Japan
    32 Kokubunji-shi Tokyo Japan
    33 Shibuya-ku Tokyo Japan
    34 Shinjuku-ku Tokyo Japan
    35 Toshima-ku Tokyo Japan
    36 Shimonoseki-shi Yamaguchi Japan
    37 Tsuru-shi Yamanashi Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Senior Manager, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01459367
    Other Study ID Numbers:
    • TAK-438/CCT-003
    • U1111-1125-1054
    • JapicCTI-111662
    First Posted:
    Oct 25, 2011
    Last Update Posted:
    Aug 23, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Esophagitis
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Aug 23, 2013