Clinical trial NCT01514240: Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Official title: A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: mild to moderate active Crohn's disease
affecting ileum
ileocecal region
ascending colon
score of 180-400 on the CDAI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 123
Sex: ALL
Minimum age (years): 15
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.

Detailed description: A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan

Eligibility criteria: Inclusion Criteria:

* 15 years of age or older
* Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation
* Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

Exclusion Criteria:

* Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)
* Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug
* Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug
* Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation

Primary outcomes:
measure: Remission After 8-week of Treatment
timeFrame: 8 Week
Secondary outcomes:
measure: Remission After 2-week of Treatment
timeFrame: 2 Week
measure: Remission After 4-week of Treatment
timeFrame: 4 Week
measure: Change in Observed CDAI Scores From Baseline to Weeks 2
timeFrame: 2 Week
measure: Change in Observed CDAI Scores From Baseline to Weeks 4
timeFrame: 4 Week
measure: Change in Observed CDAI Scores From Baseline to Weeks 8
timeFrame: 8 Week
measure: Cumulative Remission Rate at Week 2
timeFrame: 2 Week
measure: Cumulative Remission Rate at Week 4
timeFrame: 4 Week
measure: Cumulative Remission Rate at Week 8
timeFrame: 8 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2
timeFrame: 2 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4
timeFrame: 4 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8
timeFrame: 8 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2
timeFrame: 2 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4
timeFrame: 4 Week
measure: Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8
timeFrame: 8 Week
measure: Change in Total IBDQ Scores From Baseline to Weeks 2
timeFrame: 2 Week
measure: Change in Total IBDQ Scores From Baseline to Weeks 4
timeFrame: 4 Week
measure: Change in Total IBDQ Scores From Baseline to Weeks 8
timeFrame: 8 Week
measure: Change in Total IBDQ Scores From Baseline to Weeks 10
timeFrame: 10 Week
measure: Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function
timeFrame: 2 Week
measure: Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function
timeFrame: 4 Week
measure: Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function
timeFrame: 8 Week
measure: Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function
timeFrame: 10 Week
measure: Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom
timeFrame: 2 Week
measure: Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom
timeFrame: 4 Week
measure: Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom
timeFrame: 8 Week
measure: Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom
timeFrame: 10 Week
measure: Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function
timeFrame: 2 Week
measure: Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function
timeFrame: 4 Week
measure: Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function
timeFrame: 8 Week
measure: Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function
timeFrame: 10 Week
measure: Change in IBDQ Scores From Baseline to Weeks 2 - Social Function
timeFrame: 2 Week
measure: Change in IBDQ Scores From Baseline to Weeks 4 - Social Function
timeFrame: 4 Week
measure: Change in IBDQ Scores From Baseline to Weeks 8 - Social Function
timeFrame: 8 Week
measure: Change in IBDQ Scores From Baseline to Weeks 10 - Social Function
timeFrame: 10 Week
Other outcomes:
Locations:
city: Chikushino-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuyama-shi
country: Japan
facility: Research Site
city: Hirosaki-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kitakyushu-shi
country: Japan
facility: Research Site
city: Koshigaya-shi
country: Japan
facility: Research Site
city: Kurume-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Nagakute-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Nishinomiya-shi
country: Japan
facility: Research Site
city: Oita-shi
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Omura-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sakura
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinjyuku-ku
country: Japan
facility: Research Site
city: Suginami-ku
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Toyoake-shi
country: Japan
facility: Research Site
city: Toyota-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Department of Internal Medicine, Keio University School of Medicine
name: Toshifumi Hibi, Professor, Chairman
role: PRINCIPAL_INVESTIGATOR
References: