Clincosm LogoSign in Get a demo

Long-term Extension Study 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
NCT01456260
Collaborator
(none)
406
Enrollment
97
Locations
3
Arms
27
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
406 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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 :
Sep 1, 2011
Actual Study Completion Date :
Dec 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 28-80 weeks.

Drug: Placebo
Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.
Experimental: TAK-438 20 mg QD

Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.

Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Active Comparator: Lansoprazole 15 mg QD

Drug: Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Other Names:
  • AG-1749

    • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events [Up to 80 weeks.]

      Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.

    Secondary Outcome Measures

    1. Change from baseline in Laboratory values [Up to 80 weeks.]

    2. Change from baseline in Electrocardiograms [Up to 80 weeks.]

    3. Change from baseline in Vital signs [Up to 80 weeks.]

    4. Change from baseline in Serum gastrin [Up to 80 weeks.]

    5. Change from baseline in Pepsinogen I and II [Up to 80 weeks.]

    6. Recurrence rate of gastric or duodenal ulcer [Up to 80 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 completed the preceding study

    3. Outpatient (including inpatient for examinations)

    Exclusion Criteria:

    1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study

    2. Participants who are scheduled to change the type and dosage regimen of NSAID

    3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study

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

    5. 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

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

    7. 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 Mebashi-shi Gunma Japan
    22 Takasaki-shi Gunma Japan
    23 Fukuyama-shi Hiroshima Japan
    24 Hatsukaichi-shi Hiroshima Japan
    25 Higashihirosima-shi Hiroshima Japan
    26 Asahikawa-shi Hokkaido Japan
    27 Hakodate-shi Hokkaido Japan
    28 Obihiro-shi Hokkaido Japan
    29 Sapporo-shi Hokkaido Japan
    30 Sunagawa-shi Hokkaido Japan
    31 Tomakomai-shi Hokkaido Japan
    32 Akashi-shi Hyogo Japan
    33 Himeji-shi Hyogo Japan
    34 Itami-shi Hyogo Japan
    35 Kako-gun Hyogo Japan
    36 Kato-shi Hyogo Japan
    37 Kobe-shi Hyogo Japan
    38 Nishinomiya-shi Hyogo Japan
    39 Higashiibaragi-gun Ibaragi Japan
    40 Koga-shi Ibaragi Japan
    41 Mito-shi Ibaragi Japan
    42 Hakusan-shi Ishikawa Japan
    43 Komatsu-shi Ishikawa Japan
    44 Takamatsu-shi Kagawa Japan
    45 Kamakura-shi Kanagawa Japan
    46 Kawasaki-shi Kanagawa Japan
    47 Sagamihara-shi Kanagawa Japan
    48 Yokohama-shi Kanagawa Japan
    49 Kochi-shi Kochi Japan
    50 Kumamoto-shi Kumamoto Japan
    51 Uji-shi Kyoto Japan
    52 Tsu-shi Mie Japan
    53 Sendai-shi Miyagi Japan
    54 Matsumoto-shi Nagano Japan
    55 Nagano-shi Nagano Japan
    56 Nagasaki-shi Nagasaki Japan
    57 Ikoma-shi Nara Japan
    58 Nara-shi Nara Japan
    59 Nigata-shi Nigata Japan
    60 Beppu-shi Oita Japan
    61 Oita-shi Oita Japan
    62 Yuhu-shi Oita Japan
    63 Kurashiki-shi Okayama Japan
    64 Higashiosaka-shi Osaka Japan
    65 Moriguchi-shi Osaka Japan
    66 Osaka-shi Osaka Japan
    67 Osakasayama-shi Osaka Japan
    68 Tondabayashi-shi Osaka Japan
    69 Ogi-shi Saga Japan
    70 Ageo-shi Saitama Japan
    71 Hiki-gun Saitama Japan
    72 Kasukabe-shi Saitama Japan
    73 Kumagaya-shi Saitama Japan
    74 Saitama-shi Saitama Japan
    75 Sayama-shi Saitama Japan
    76 Toda-shi Saitama Japan
    77 Tokorozawa-shi Saitama Japan
    78 Otsu-shi Shiga Japan
    79 Hamamatsu-shi Shizuoka Japan
    80 Shizuoka-shi Shizuoka Japan
    81 Naruto-shi Tokushima Japan
    82 Adachi-ku Tokyo Japan
    83 Bunkyo-ku Tokyo Japan
    84 Hachiouji-shi Tokyo Japan
    85 Koto-ku Tokyo Japan
    86 Meguro-ku Tokyo Japan
    87 Minato-ku Tokyo Japan
    88 Musashimurayama-shi Tokyo Japan
    89 Nakano-ku Tokyo Japan
    90 Ota-ku Tokyo Japan
    91 Setagaya-ku Tokyo Japan
    92 Sumida-ku Tokyo Japan
    93 Yonago-shi Tottori Japan
    94 Tonami-shi Toyama Japan
    95 Toyama-shi Toyama Japan
    96 Shimonoseki-shi Yamaguchi Japan
    97 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:
    NCT01456260
    Other Study ID Numbers:
    • TAK-438/OCT-301
    • U1111-1123-8762
    • JapicCTI-111611
    First Posted:
    Oct 20, 2011
    Last Update Posted:
    May 8, 2014
    Last Verified:
    May 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 May 8, 2014