Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

PHASE3CompletedINTERVENTIONAL
Enrollment

621

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 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 (76)

Unknown

Komaki-shi

Seto-shi

Akita

Ichikawa-shi

Kisarazu-shi

Matsudo-shi

Imabari

Matsuyama

Niihama-shi

Fukui-shi

Chikushino-shi

Fukuoka

Kasuya-gun

Kitakyushu-shi

Miyako-gun

Onga-gun

Yanagawa-shi

Yukuhashi-shi

Koriyama-shi

Gifu

Takasaki-shi

Fukuyama-shi

Hatsukaichi-shi

Hiroshima

Asahikawa-shi

Obihiro-shi

Sapporo

Tomakomaki-shi

Kobe

Nishinomiya-shi

Takarazuka-shi

Koga-shi

Tsuchiura-shi

Kanazawa

Komatsu-shi

Nomi-shi

Shiroyama-shi

Takamatsu

Ibusuki-shi

Ichikikushikino-shi

Izumi-shi

Atsugi-shi

Kawasaki-shi

Sagamihara-shi

Yokohama

Kochi

Kumamoto

Kyoto

Uji-shi

Tsu

Sendai

Nagasaki

Nara

Niigata

Ōita

Osaka

Sakai-shi

Tondabayashi-shi

Ageo-shi

Hiki-gun

Kumagaya-shi

Saitama-shi

Sayama-shi

Tokorozawa-shi

Ōtsu

Utsunomiya

Adachi-ku

Hachioji-shi

Koto-ku

Meguro-ku

Minato-ku

Shinjuku-ku

Tonami-shi

Toyama

Iwakuni-shi

Shimonoseki-shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY