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

PHASE3CompletedINTERVENTIONAL
Enrollment

642

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Gastric UlcersDuodenal Ulcers
Interventions
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.

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.

DRUG

Lansoprazole

Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.

DRUG

Placebo

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

Trial Locations (102)

Unknown

Kasugai-shi

Nagoya

Seto-shi

Akita

Funabashi-shi

Ichihara-shi

Nagareyama-shi

Matsuyama

Niihama-shi

Saijo-shi

Fukui-shi

Fukuoka

Itoshima-shi

Kitakyusyu-shi

Munakata-shi

Onga-gun

Tagawa-shi

Yukuhashi-shi

Fukushima

Koriyama-shi

Gifu

Mebashi-shi

Takasaki-shi

Fukuyama-shi

Hatsukaichi-shi

Higashihirosima-shi

Asahikawa-shi

Hakodate-shi

Obihiro-shi

Sapporo

Sunagawa-shi

Tomakomai-shi

Akashi-shi

Himeji-shi

Itami-shi

Kako-gun

Kato-shi

Kobe

Nishinomiya-shi

Higashiibaragi-gun

Koga-shi

Mito

Hitachi-shi

Hakusan-shi

Komatsu-shi

Takamatsu

Kamakura-shi

Kawasaki-shi

Sagamihara-shi

Yokohama

Kochi

Kumamoto

Uji-shi

Tsu

Sendai

Matsumoto-shi

Nagano

Nagasaki

Ikoma-shi

Nara

Nigata-shi

Beppu-shi

Ōita

Yuhu-shi

Kurashiki-shi

Higashiosaka-shi

Moriguchi-shi

Osaka

Osakasayama-shi

Tondabayashi-shi

Ogi-shi

Saga

Ageo-shi

Hiki-gun

Kasukabe-shi

Kumagaya-shi

Saitama-shi

Sayama-shi

Toda-shi

Tokorozawa-shi

Ōtsu

Izumo-shi

Hamamatsu

Shizuoka

Naruto-shi

Adachi-ku

Bunkyo-ku

Hachiouji-shi

Koto-ku

Meguro-ku

Minato-ku

Mitaka-shi

Musashimurayama-shi

Nakano-ku

Ōta-ku

Setagaya-ku

Sumida-ku

Yonago-shi

Tonami-shi

Toyama

Shimonoseki-shi

Ube-shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY