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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514240
• Other study ID #: D9423C00001
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2012
• Last updated: September 16, 2014
• Start date: February 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Research Site	Chikushino-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuyama-shi
Japan	Research Site	Hirosaki-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kitakyushu-shi
Japan	Research Site	Koshigaya-shi
Japan	Research Site	Kurume-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Nagakute-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nishinomiya-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Omura-shi
Japan	Research Site	Osaka
Japan	Research Site	Osaka-shi
Japan	Research Site	Sakura
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinjyuku-ku
Japan	Research Site	Suginami-ku
Japan	Research Site	Suita-shi
Japan	Research Site	Toyoake-shi
Japan	Research Site	Toyota-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy change 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.		baseline and Week-8	No
Secondary	Remission (ie, CDAI score of =150) after 2-week treatment		baseline and Week-2	Yes
Secondary	Remission (ie, CDAI score of =150) after 4-week treatment		baseline and Week-4	Yes
Secondary	Change in CDAI score		baseline and after 2-week	Yes
Secondary	Change in CDAI score		baseline and Week-4	Yes
Secondary	Change in CDAI score		baseline and Week-8	Yes
Secondary	Time to the first remission		up to 8th Week of treatment	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 100 from baseline		baseline and week-2	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 100 from baseline		baseline and week-4	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 100 from baseline		baseline and Week-8	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 70 from baseline		baseline and Week-2	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 70 from baseline		baseline and Week-4	Yes
Secondary	Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 70 from baseline		baseline and week-8	Yes
Secondary	Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores		baseline and Week-2	Yes
Secondary	Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores		baseline and Week-4	Yes
Secondary	Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores		baseline and Week-8	Yes