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Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01456247
Collaborator
(none)
439
Enrollment
76
Locations
3
Arms
19
Duration (Months)
5.8
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 safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
439 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 Low-dose Aspirin
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 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: AG-1749 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 low-dose aspirin 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 low-dose aspirin

    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 Komaki-shi Aichi Japan
    2 Seto-shi Aichi Japan
    3 Akita-shi Akita Japan
    4 Ichikawa-shi Chiba Japan
    5 Kisarazu-shi Chiba Japan
    6 Matsudo-shi Chiba Japan
    7 Imabari-shi Ehime Japan
    8 Matsuyama-shi Ehime Japan
    9 Niihama-shi Ehime Japan
    10 Fukui-shi Fukui Japan
    11 Chikushino-shi Fukuoka Japan
    12 Fukuoka-shi Fukuoka Japan
    13 Kasuya-gun Fukuoka Japan
    14 Kitakyushu-shi Fukuoka Japan
    15 Miyako-gun Fukuoka Japan
    16 Onga-gun Fukuoka Japan
    17 Yanagawa-shi Fukuoka Japan
    18 Yukuhashi-shi Fukuoka Japan
    19 Koriyama-shi Fukushima Japan
    20 Gifu-shi Gifu Japan
    21 Takasaki-shi Gunma Japan
    22 Fukuyama-shi Hiroshima Japan
    23 Hatsukaichi-shi Hiroshima Japan
    24 Hiroshima-shi Hiroshima Japan
    25 Asahikawa-shi Hokkaido Japan
    26 Obihiro-shi Hokkaido Japan
    27 Sapporo-shi Hokkaido Japan
    28 Tomakomaki-shi Hokkaido Japan
    29 Kobe-shi Hyougo Japan
    30 Nishinomiya-shi Hyougo Japan
    31 Takarazuka-shi Hyougo Japan
    32 Koga-shi Ibaragi Japan
    33 Tsuchiura-shi Ibaragi Japan
    34 Kanazawa-shi Ishikawa Japan
    35 Komatsu-shi Ishikawa Japan
    36 Nomi-shi Ishikawa Japan
    37 Shiroyama-shi Ishikawa Japan
    38 Takamatsu-shi Kagawa Japan
    39 Ibusuki-shi Kagoshima Japan
    40 Ichikikushikino-shi Kagoshima Japan
    41 Izumi-shi Kagoshima Japan
    42 Atsugi-shi Kanagawa Japan
    43 Kawasaki-shi Kanagawa Japan
    44 Sagamihara-shi Kanagawa Japan
    45 Yokohama-shi Kanagawa Japan
    46 Kochi-shi Kochi Japan
    47 Kumamoto-shi Kumamoto Japan
    48 Kyoto-shi Kyoto Japan
    49 Uji-shi Kyoto Japan
    50 Tsu-shi Mie Japan
    51 Sendai-shi Miyagi Japan
    52 Nagasaki-shi Nagasaki Japan
    53 Nara-shi Nara Japan
    54 Niigata-shi Niigata Japan
    55 Oita-shi Oita Japan
    56 Osaka-shi Osaka Japan
    57 Sakai-shi Osaka Japan
    58 Tondabayashi-shi Osaka Japan
    59 Ageo-shi Saitama Japan
    60 Hiki-gun Saitama Japan
    61 Kumagaya-shi Saitama Japan
    62 Saitama-shi Saitama Japan
    63 Sayama-shi Saitama Japan
    64 Tokorozawa-shi Saitama Japan
    65 Otsu-shi Shiga Japan
    66 Utsunomiya-shi Tochigi Japan
    67 Adachi-ku Tokyo Japan
    68 Hachioji-shi Tokyo Japan
    69 Koto-ku Tokyo Japan
    70 Meguro-ku Tokyo Japan
    71 Minato-ku Tokyo Japan
    72 Shinjuku-ku Tokyo Japan
    73 Tonami-shi Toyama Japan
    74 Toyama-shi Toyama Japan
    75 Iwakuni-shi Yamaguchi Japan
    76 Shimonoseki-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:
    NCT01456247
    Other Study ID Numbers:
    • TAK-438/OCT-302
    • U1111-1123-9658
    • JapicCTI-111616
    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