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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01514240
First received: January 10, 2012
Last updated: September 16, 2014
Last verified: September 2014

January 10, 2012
September 16, 2014
February 2012
September 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514240 on ClinicalTrials.gov Archive Site
  • Remission (ie, CDAI score of ≤150) after 2-week treatment [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • Remission (ie, CDAI score of ≤150) after 4-week treatment [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and after 2-week ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]
  • Time to the first remission [ Time Frame: up to 8th Week of treatment ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and week-2 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and week-4 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and week-8 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • 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.
  • Experimental: D9421-C
    D9421-C 9 mg once daily
    Intervention: Drug: D9421-C capsule 3 mg
  • Active Comparator: Mesalazine
    Mesalazine 1 g three times a day
    Intervention: Drug: Mesalazine tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01514240
D9423C00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Toshifumi Hibi, Professor, Chairman Department of Internal Medicine, Keio University School of Medicine
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP