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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 8, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Crohn's Disease
Drug: D9421-C capsule 3 mg
Drug: Mesalazine tablets
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Remission After 8-week of Treatment [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.


Secondary Outcome Measures:
  • Remission After 2-week of Treatment [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    For the secondary efficacy variable "Remission after 2 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.

  • Remission After 4-week of Treatment [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    For the secondary efficacy variable "Remission after 4 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.

  • Change in Observed CDAI Scores From Baseline to Weeks 2 [ Time Frame: 2 Week ] [ Designated as safety issue: No ]

    Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

    Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.


  • Change in Observed CDAI Scores From Baseline to Weeks 4 [ Time Frame: 4 Week ] [ Designated as safety issue: No ]

    Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

    Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.


  • Change in Observed CDAI Scores From Baseline to Weeks 8 [ Time Frame: 8 Week ] [ Designated as safety issue: No ]

    Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

    Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.


  • Cumulative Remission Rate at Week 2 [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.

  • Cumulative Remission Rate at Week 4 [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.

  • Cumulative Remission Rate at Week 8 [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

  • Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

  • Change in Total IBDQ Scores From Baseline to Weeks 2 [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in Total IBDQ Scores From Baseline to Weeks 4 [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in Total IBDQ Scores From Baseline to Weeks 8 [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in Total IBDQ Scores From Baseline to Weeks 10 [ Time Frame: 10 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function [ Time Frame: 10 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom [ Time Frame: 10 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function [ Time Frame: 10 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 2 - Social Function [ Time Frame: 2 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 4 - Social Function [ Time Frame: 4 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 8 - Social Function [ Time Frame: 8 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

  • Change in IBDQ Scores From Baseline to Weeks 10 - Social Function [ Time Frame: 10 Week ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.


Enrollment: 123
Study Start Date: February 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D9421-C
D9421-C 9 mg once daily
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.
Active Comparator: Mesalazine
Mesalazine 1 g three times a day
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.

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

Ages Eligible for Study:   15 Years to 130 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514240

Locations
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-shi, Japan
Research Site
Osaka, 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, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Toshifumi Hibi, Professor, Chairman Department of Internal Medicine, Keio University School of Medicine
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01514240     History of Changes
Other Study ID Numbers: D9423C00001 
Study First Received: January 10, 2012
Results First Received: March 4, 2015
Last Updated: September 8, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
mild to moderate active Crohn's disease
affecting ileum
ileocecal region
ascending colon
score of 180-400 on the CDAI

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 02, 2016