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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01452698
Collaborator
(none)
409
Enrollment
32
Locations
2
Arms
12.8
Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
409 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 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAK-438 20 mg QD

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

Drug: Placebo
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.
Other Names:
  • AG-1749

    		•
    Active Comparator: AG-1749 30 mg QD

    Drug: Lansoprazole
    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.
    Other Names:
  • AG-1749

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

    Outcome Measures

    Primary Outcome Measures

    1. Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis [8 Weeks]

      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).

    Secondary Outcome Measures

    1. Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis [2 Weeks]

    2. Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis [4 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 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:

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya-shi Aichi Japan
    2 Abiko-shi Chiba Japan
    3 Fukuoka-shi Fukuoka Japan
    4 Itoshima-shi Fukuoka Japan
    5 Kurume-shi Fukuoka Japan
    6 Onga-gun Fukuoka Japan
    7 Gifu-shi Gifu Japan
    8 Annaka-shi Gunma Japan
    9 Aki-gun Hiroshima Japan
    10 Hiroshima-shi Hiroshima Japan
    11 Sapporo-shi Hokkaido Japan
    12 Amagasaki-shi Hyogo Japan
    13 Kobe-shi Hyogo Japan
    14 Takarazuka-shi Hyogo Japan
    15 Sakade-shi Kagawa Japan
    16 Yokohama-shi Kanagawa Japan
    17 Kochi-shi Kochi Japan
    18 Susaki-shi Kochi Japan
    19 Kumamoto-shi Kumamoto Japan
    20 Kyoto-shi Kyoto Japan
    21 Nagasaki-shi Nagasaki Japan
    22 Oita-shi Oita Japan
    23 Okayama-shi Okayama Japan
    24 Fuziidera-shi Osaka Japan
    25 Shizuoka-shi Shizuoka Japan
    26 Otawara-shi Tochigi Japan
    27 Chiyoda-ku Tokyo Japan
    28 Chuo-ku Tokyo Japan
    29 Nakano-ku Tokyo Japan
    30 Ota-ku Tokyo Japan
    31 Setagaya-ku Tokyo Japan
    32 Yamagata-shi Yamagata 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:
    NCT01452698
    Other Study ID Numbers:
    • TAK-438/CCT-002
    • U1111-1123-8356
    • JapicCTI-111607
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    Nov 9, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Esophagitis
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Nov 9, 2012