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)

PHASE3CompletedINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

September 30, 2011

Study Completion Date

December 31, 2013

Conditions
Gastric UlcersDuodenal Ulcers
Interventions
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.

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.

DRUG

Lansoprazole

Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.

DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

Trial Locations (97)

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

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

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

Ageo-shi

Hiki-gun

Kasukabe-shi

Kumagaya-shi

Saitama-shi

Sayama-shi

Toda-shi

Tokorozawa-shi

Ōtsu

Hamamatsu

Shizuoka

Naruto-shi

Adachi-ku

Bunkyo-ku

Hachiouji-shi

Koto-ku

Meguro-ku

Minato-ku

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