Crohn's DiseasePhase 3NCT01514240
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
A Phase 3 study testing D9421-C capsule 3 mg and Mesalazine tablets in people with Crohn's Disease, run by AstraZeneca at 25 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 15 to 130 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- D9421-C capsule 3 mg and Mesalazine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 25 sitesJapan
- Study dates
- Feb 2012to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Research Site
Chikushino-shi
Research Site
Fukuoka
Research Site
Fukuyama-shi
Research Site
Hirosaki-shi
Research Site
Hiroshima
Research Site
Kagoshima
Research Site
Kitakyushu-shi
Research Site
Koshigaya-shi
Research Site
Kurume-shi
Research Site
Kyoto
Research Site
Nagakute-shi
Research Site
Nagoya
Research Site
Nishinomiya-shi
Research Site
Ōita
Research Site
Okayama
Research Site
Omura-shi
Research Site
Osaka
Research Site
Sakura
Research Site
Sapporo
Research Site
Sendai
Research Site
Shinjyuku-ku
Research Site
Suginami-ku
Research Site
Suita-shi
Research Site
Toyoake-shi
Research Site
Toyota-shi
About this study
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
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.
Read the 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
- Conditions
- Crohn's Disease
- Being tested
- D9421-C capsule 3 mg, Mesalazine tablets
- Keywords
- mild to moderate active Crohn's disease, affecting ileum, ileocecal region, ascending colon, score of 180-400 on the CDAI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D9421-C capsule 3 mgDrug
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 tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| D9421-C | Experimental | D9421-C 9 mg once daily Receives: Drug: D9421-C capsule 3 mg |
| Mesalazine | Active comparator | Mesalazine 1 g three times a day Receives: Drug: Mesalazine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission After 8-week of Treatment
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.
Measured: 8 Week
Secondary outcomes (34)
Remission After 2-week of Treatment
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.
Measured: 2 Week
Remission After 4-week of Treatment
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.
Measured: 4 Week
Change in Observed CDAI Scores From Baseline to Weeks 2
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.
Measured: 2 Week
Change in Observed CDAI Scores From Baseline to Weeks 4
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.
Measured: 4 Week
Change in Observed CDAI Scores From Baseline to Weeks 8
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.
Measured: 8 Week
Cumulative Remission Rate at Week 2
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.
Measured: 2 Week
Cumulative Remission Rate at Week 4
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.
Measured: 4 Week
Cumulative Remission Rate at Week 8
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.
Measured: 8 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
Measured: 2 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
Measured: 4 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
Measured: 8 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
Measured: 2 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
Measured: 4 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
Measured: 8 Week
Change in Total IBDQ Scores From Baseline to Weeks 2
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.
Measured: 2 Week
Change in Total IBDQ Scores From Baseline to Weeks 4
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.
Measured: 4 Week
Change in Total IBDQ Scores From Baseline to Weeks 8
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.
Measured: 8 Week
Change in Total IBDQ Scores From Baseline to Weeks 10
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.
Measured: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function
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.
Measured: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function
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.
Measured: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function
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.
Measured: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function
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.
Measured: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom
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.
Measured: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom
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.
Measured: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom
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.
Measured: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom
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.
Measured: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function
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.
Measured: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function
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.
Measured: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function
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.
Measured: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function
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.
Measured: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Social Function
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.
Measured: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Social Function
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.
Measured: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Social Function
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.
Measured: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Social Function
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.
Measured: 10 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshifumi Hibi, Professor, Chairman, Principal investigator, Department of Internal Medicine, Keio University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514240
- Sponsor's protocol ID
- D9423C00001
- Status last verified
- Sep 2016
- First submitted
- 10 Jan 2012
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01514240
- Acronym / sponsor ID
- D9423C00001
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D9421-C | Experimental | Drug: D9421-C capsule 3 mgD9421-C 9 mg once daily |
| Mesalazine | Active comparator | Drug: Mesalazine tabletsMesalazine 1 g three times a day |
Who may qualify
- Ages
- 15 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D9421-C capsule 3 mgPatients 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 | D9421-C |
| Mesalazine tabletsPatients 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. | Drug | Mesalazine |
Primary outcome
Remission After 8-week of Treatment
Time frame: 8 Week
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.
34 secondary outcomes
Remission After 2-week of Treatment
Time frame: 2 Week
Remission After 4-week of Treatment
Time frame: 4 Week
Change in Observed CDAI Scores From Baseline to Weeks 2
Time frame: 2 Week
Change in Observed CDAI Scores From Baseline to Weeks 4
Time frame: 4 Week
Change in Observed CDAI Scores From Baseline to Weeks 8
Time frame: 8 Week
Cumulative Remission Rate at Week 2
Time frame: 2 Week
Cumulative Remission Rate at Week 4
Time frame: 4 Week
Cumulative Remission Rate at Week 8
Time frame: 8 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2
Time frame: 2 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4
Time frame: 4 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8
Time frame: 8 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2
Time frame: 2 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4
Time frame: 4 Week
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8
Time frame: 8 Week
Change in Total IBDQ Scores From Baseline to Weeks 2
Time frame: 2 Week
Change in Total IBDQ Scores From Baseline to Weeks 4
Time frame: 4 Week
Change in Total IBDQ Scores From Baseline to Weeks 8
Time frame: 8 Week
Change in Total IBDQ Scores From Baseline to Weeks 10
Time frame: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function
Time frame: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function
Time frame: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function
Time frame: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function
Time frame: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom
Time frame: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom
Time frame: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom
Time frame: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom
Time frame: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function
Time frame: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function
Time frame: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function
Time frame: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function
Time frame: 10 Week
Change in IBDQ Scores From Baseline to Weeks 2 - Social Function
Time frame: 2 Week
Change in IBDQ Scores From Baseline to Weeks 4 - Social Function
Time frame: 4 Week
Change in IBDQ Scores From Baseline to Weeks 8 - Social Function
Time frame: 8 Week
Change in IBDQ Scores From Baseline to Weeks 10 - Social Function
Time frame: 10 Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshifumi Hibi, Professor, Chairman principal investigator
Department of Internal Medicine, Keio University School of Medicine
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D9421-C capsule 3 mg and Mesalazine tablets in people with Crohn's Disease, run by AstraZeneca at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission After 8-week of Treatment (time frame: 8 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.