Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

PHASE3CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Crohn's Disease
Interventions
DRUG

D9421-C capsule 3 mg

Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.

DRUG

Mesalazine tablets

Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.

Trial Locations (25)

Unknown

Research Site, Chikushino-shi

Research Site, Fukuoka

Research Site, Fukuyama-shi

Research Site, Hirosaki-shi

Research Site, Hiroshima

Research Site, Kagoshima

Research Site, Kitakyushu-shi

Research Site, Koshigaya-shi

Research Site, Kurume-shi

Research Site, Kyoto

Research Site, Nagakute-shi

Research Site, Nagoya

Research Site, Nishinomiya-shi

Research Site, Okayama

Research Site, Omura-shi

Research Site, Osaka

Research Site, Ōita

Research Site, Sakura

Research Site, Sapporo

Research Site, Sendai

Research Site, Shinjyuku-ku

Research Site, Suginami-ku

Research Site, Suita-shi

Research Site, Toyoake-shi

Research Site, Toyota-shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT01514240 - Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan | Biotech Hunter | Biotech Hunter