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Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01452750
Collaborator
(none)
642
Enrollment
102
Locations
3
Arms
20
Duration (Months)
6.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
642 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Drug: TAK-438
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.

Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Experimental: TAK-438 20 mg QD

Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.

Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Active Comparator: Lansoprazole 15 mg QD

Drug: Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Other Names:
  • AG-1749

    • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence rate of gastric or duodenal ulcer within 24 weeks [24 weeks]

      Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.

    Secondary Outcome Measures

    1. Recurrence rate of gastric or duodenal ulcer within 12 weeks [12 weeks]

    2. Gastric mucosal injury [24 Weeks]

    3. Duodenal mucosal injury [24 weeks]

    4. Occurrence rate of hemorrhagic lesion in stomach or duodenum [24 weeks]

    5. Time to recurrence of gastric or duodenal ulcer [24 weeks]

    Eligibility Criteria

    Criteria

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

    1. Participants who require continuous NSAID therapy during the treatment period with the study drug

    2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed

    3. Outpatient (including inpatient for examinations)

    Exclusion Criteria:

    1. Participants scheduled to change the type and dosage regimen of NSAID

    2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed

    3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology

    4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery

    5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders

    6. Participants with a previous or current history of aspirin-induced asthma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasugai-shi Aichi Japan
    2 Nagoya-shi Aichi Japan
    3 Seto-shi Aichi Japan
    4 Akita-shi Akita Japan
    5 Funabashi-shi Chiba Japan
    6 Ichihara-shi Chiba Japan
    7 Nagareyama-shi Chiba Japan
    8 Matsuyama-shi Ehime Japan
    9 Niihama-shi Ehime Japan
    10 Saijo-shi Ehime Japan
    11 Fukui-shi Fukui Japan
    12 Fukuoka-shi Fukuoka Japan
    13 Itoshima-shi Fukuoka Japan
    14 Kitakyusyu-shi Fukuoka Japan
    15 Munakata-shi Fukuoka Japan
    16 Onga-gun Fukuoka Japan
    17 Tagawa-shi Fukuoka Japan
    18 Yukuhashi-shi Fukuoka Japan
    19 Fukushima-shi Fukushima Japan
    20 Koriyama-shi Fukushima Japan
    21 Gifu-shi Gifu Japan
    22 Mebashi-shi Gunma Japan
    23 Takasaki-shi Gunma Japan
    24 Fukuyama-shi Hiroshima Japan
    25 Hatsukaichi-shi Hiroshima Japan
    26 Higashihirosima-shi Hiroshima Japan
    27 Asahikawa-shi Hokkaido Japan
    28 Hakodate-shi Hokkaido Japan
    29 Obihiro-shi Hokkaido Japan
    30 Sapporo-shi Hokkaido Japan
    31 Sunagawa-shi Hokkaido Japan
    32 Tomakomai-shi Hokkaido Japan
    33 Akashi-shi Hyogo Japan
    34 Himeji-shi Hyogo Japan
    35 Itami-shi Hyogo Japan
    36 Kako-gun Hyogo Japan
    37 Kato-shi Hyogo Japan
    38 Kobe-shi Hyogo Japan
    39 Nishinomiya-shi Hyogo Japan
    40 Higashiibaragi-gun Ibaragi Japan
    41 Koga-shi Ibaragi Japan
    42 Mito-shi Ibaragi Japan
    43 Hitachi-shi Ibaraki Japan
    44 Hakusan-shi Ishikawa Japan
    45 Komatsu-shi Ishikawa Japan
    46 Takamatsu-shi Kagawa Japan
    47 Kamakura-shi Kanagawa Japan
    48 Kawasaki-shi Kanagawa Japan
    49 Sagamihara-shi Kanagawa Japan
    50 Yokohama-shi Kanagawa Japan
    51 Kochi-shi Kochi Japan
    52 Kumamoto-shi Kumamoto Japan
    53 Uji-shi Kyoto Japan
    54 Tsu-shi Mie Japan
    55 Sendai-shi Miyagi Japan
    56 Matsumoto-shi Nagano Japan
    57 Nagano-shi Nagano Japan
    58 Nagasaki-shi Nagasaki Japan
    59 Ikoma-shi Nara Japan
    60 Nara-shi Nara Japan
    61 Nigata-shi Nigata Japan
    62 Beppu-shi Oita Japan
    63 Oita-shi Oita Japan
    64 Yuhu-shi Oita Japan
    65 Kurashiki-shi Okayama Japan
    66 Higashiosaka-shi Osaka Japan
    67 Moriguchi-shi Osaka Japan
    68 Osaka-shi Osaka Japan
    69 Osakasayama-shi Osaka Japan
    70 Tondabayashi-shi Osaka Japan
    71 Ogi-shi Saga Japan
    72 Saga-shi Saga Japan
    73 Ageo-shi Saitama Japan
    74 Hiki-gun Saitama Japan
    75 Kasukabe-shi Saitama Japan
    76 Kumagaya-shi Saitama Japan
    77 Saitama-shi Saitama Japan
    78 Sayama-shi Saitama Japan
    79 Toda-shi Saitama Japan
    80 Tokorozawa-shi Saitama Japan
    81 Otsu-shi Shiga Japan
    82 Izumo-shi Shimane Japan
    83 Hamamatsu-shi Shizuoka Japan
    84 Shizuoka-shi Shizuoka Japan
    85 Naruto-shi Tokushima Japan
    86 Adachi-ku Tokyo Japan
    87 Bunkyo-ku Tokyo Japan
    88 Hachiouji-shi Tokyo Japan
    89 Koto-ku Tokyo Japan
    90 Meguro-ku Tokyo Japan
    91 Minato-ku Tokyo Japan
    92 Mitaka-shi Tokyo Japan
    93 Musashimurayama-shi Tokyo Japan
    94 Nakano-ku Tokyo Japan
    95 Ota-ku Tokyo Japan
    96 Setagaya-ku Tokyo Japan
    97 Sumida-ku Tokyo Japan
    98 Yonago-shi Tottori Japan
    99 Tonami-shi Toyama Japan
    100 Toyama-shi Toyama Japan
    101 Shimonoseki-shi Yamaguchi Japan
    102 Ube-shi Yamaguchi 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:
    NCT01452750
    Other Study ID Numbers:
    • TAK-438/CCT-301
    • U1111-1123-8722
    • JapicCTI-111613
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    Feb 5, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Stomach Ulcer
    Duodenal Ulcer
    Ulcer
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Feb 5, 2014