Clinical trial NCT00573469: Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Official title: A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: gastrointestinal
GI
Crohn's disease
Japan
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.


Eligibility criteria: Inclusion Criteria:

* Female or male aged ≥ 18 and ≤ 65 years
* Diagnosis of Crohn's Disease

Exclusion Criteria:

* Having ileostomy or pouch and/or colostomy
* Having previous gastric surgery
* Having a known or suspected systemic infection

Primary outcomes:
measure: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment
timeFrame: Baseline to 2 weeks
measure: Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment
timeFrame: Baseline to 4 weeks
measure: Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method
timeFrame: At 8 weeks
measure: Change in CDAI Score From Baseline to 8 Weeks
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Sakura
country: Japan
facility: Research Site
state: Chiba
city: Chikushino
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Hashima-gun
country: Japan
facility: Research Site
state: Gifu
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Tokorozawa
country: Japan
facility: Research Site
state: Saitama
city: Shinjuku-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Itami
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nishinomiya
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Masataka Date, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Suzuki Y, Motoya S, Takazoe M, Kosaka T, Date M, Nii M, Hibi T. Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study. J Crohns Colitis. 2013 Apr;7(3):239-47. doi: 10.1016/j.crohns.2012.06.006. Epub 2012 Jul 4.