Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

Last updated: July 2, 2013
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01474369
TAK-438/CCT-201
JapicCTI-111663
U1111-1125-1115
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with grade N or M in the modified LA classification system confirmed byendoscopy at initiation of the pre-observation period (VISIT 1).

  2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2days or more in one week in the 3 weeks before initiation of initiation of thepre-observation period (VISIT 1).

  3. Participants with severity* of moderate or higher for acid reflux symptoms (heartburnor regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)

  • Severity: No symptoms, very mild (symptoms present but often forgotten), mild (notso painful), moderate (rather painful), severe (painful) and very severe (painfulenough to affect night time sleep or daily activities)
  1. Outpatients (hospitalization for testing possible)

Exclusion

Exclusion Criteria:

  1. Participants with an esophagus-related complication [Barrett's esophagus (3 cm ormore, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral orfungal infections, esophageal stenosis, etc.], or a history of radiotherapy orcryotherapy of the esophagus, a caustic or physiochemical trauma (esophagealsclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm,SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter)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.), orwho have a history of surgery of stomach or duodenum (excluding removal of benignpolyp under endoscopy)

  3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosaldefects associated with white coating) or duodenal ulcers (mucosal defect with whitecoating) within 30 days before initiation of the pre-observation period (VISIT 1)However, participants with gastric or duodenal erosions are allowed to be included.

  4. Participants with acute gastritis or acute exacerbation of chronic gastritis as acomplication

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

  6. Participants with a history of chest pain due to heart disease or with chest painssuspected of being caused by heart disease within one year before initiation of thepre-observation period (VISIT 1)

Study Design

Total Participants: 827
Study Start date:
December 01, 2011
Estimated Completion Date:
February 28, 2013

Connect with a study center

  • Nagoya-shi, Aichi
    Japan

    Site Not Available

  • Abiko-shi, Chiba
    Japan

    Site Not Available

  • Kashiwa-shi, Chiba
    Japan

    Site Not Available

  • Noda-shi, Chiba
    Japan

    Site Not Available

  • Yachiyo-shi, Chiba
    Japan

    Site Not Available

  • Saijo-shi, Ehime
    Japan

    Site Not Available

  • Fukuoka-shi, Fukuoka
    Japan

    Site Not Available

  • Itoshima-shi, Fukuoka
    Japan

    Site Not Available

  • Kasuya-gun, Fukuoka
    Japan

    Site Not Available

  • Onga-gun, Fukuoka
    Japan

    Site Not Available

  • Kouriyama-shi, Fukushima
    Japan

    Site Not Available

  • Gifu-shi, Gifu
    Japan

    Site Not Available

  • Takayama-shi, Gifu
    Japan

    Site Not Available

  • Annaka-shi, Gunma
    Japan

    Site Not Available

  • Hiroshima-shi, Hiroshima
    Japan

    Site Not Available

  • Asahikawa-shi, Hokkaido
    Japan

    Site Not Available

  • Sapporo-shi, Hokkaido
    Japan

    Site Not Available

  • Amagasaki-shi, Hyogo
    Japan

    Site Not Available

  • Kobe-shi, Hyogo
    Japan

    Site Not Available

  • Nishinomiya-shi, Hyogo
    Japan

    Site Not Available

  • Takarazuka-shi, Hyogo
    Japan

    Site Not Available

  • Sagamihara-shi, Kanagawa
    Japan

    Site Not Available

  • Yokohama-shi, Kanagawa
    Japan

    Site Not Available

  • Kochi-shi, Kochi
    Japan

    Site Not Available

  • Suzaki-shi, Kochi
    Japan

    Site Not Available

  • Kumamoto-shi, Kumamoto
    Japan

    Site Not Available

  • Kyoto-shi, Kyoto
    Japan

    Site Not Available

  • Sendai-shi, Miyagi
    Japan

    Site Not Available

  • Nagasaki-shi, Nagasaki
    Japan

    Site Not Available

  • Oita-shi, Oita
    Japan

    Site Not Available

  • Okayama-shi, Okayama
    Japan

    Site Not Available

  • Osaka-shi, Osaka
    Japan

    Site Not Available

  • Takatsuki-shi, Osaka
    Japan

    Site Not Available

  • Saga-shi, Saga
    Japan

    Site Not Available

  • Kumagaya-shi, Saitama
    Japan

    Site Not Available

  • Saitama-shi, Saitama
    Japan

    Site Not Available

  • Tokorozawa-shi, Saitama
    Japan

    Site Not Available

  • Otawara-shi, Tochigi
    Japan

    Site Not Available

  • Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • Chiyoda-ku, Tokyo
    Japan

    Site Not Available

  • Chuo-ku, Tokyo
    Japan

    Site Not Available

  • Hachioji-shi, Tokyo
    Japan

    Site Not Available

  • Kokubunji-shi, Tokyo
    Japan

    Site Not Available

  • Nakano-ku, Tokyo
    Japan

    Site Not Available

  • Oota-ku, Tokyo
    Japan

    Site Not Available

  • Setagaya-ku, Tokyo
    Japan

    Site Not Available

  • Shibuya-ku, Tokyo
    Japan

    Site Not Available

  • Shinjuku-ku, Tokyo
    Japan

    Site Not Available

  • Shimonoseki-shi, Yamaguchi
    Japan

    Site Not Available

  • Kofu-shi, Yamanashi
    Japan

    Site Not Available

  • Turu-shi, Yamanashi
    Japan

    Site Not Available

  • Yamagata-shi, Ymagata
    Japan

    Site Not Available

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