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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Remission After 8-week of Treatment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 130 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
D9421-C
D9421-C 9 mg once daily
干预措施: D9421-C capsule 3 mg (Drug)
Mesalazine
Mesalazine 1 g three times a day
干预措施: Mesalazine tablets (Drug)
结局指标
主要结局
Remission After 8-week of Treatment
时间窗: 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.
次要结局
- Change in Observed CDAI Scores From Baseline to Weeks 4(4 Week)
- Change in Observed CDAI Scores From Baseline to Weeks 8(8 Week)
- Cumulative Remission Rate at Week 4(4 Week)
- Cumulative Remission Rate at Week 8(8 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8(8 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2(2 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4(4 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8(8 Week)
- Change in Total IBDQ Scores From Baseline to Weeks 2(2 Week)
- Change in Total IBDQ Scores From Baseline to Weeks 4(4 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2(2 Week)
- Remission After 2-week of Treatment(2 Week)
- Remission After 4-week of Treatment(4 Week)
- Cumulative Remission Rate at Week 2(2 Week)
- Change in Observed CDAI Scores From Baseline to Weeks 2(2 Week)
- Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4(4 Week)
- Change in Total IBDQ Scores From Baseline to Weeks 8(8 Week)
- Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function(8 Week)
- Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function(10 Week)
- Change in Total IBDQ Scores From Baseline to Weeks 10(10 Week)
- Change in IBDQ Scores From Baseline to Weeks 2 - Social Function(2 Week)
- Change in IBDQ Scores From Baseline to Weeks 4 - Social Function(4 Week)
- Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function(2 Week)
- Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function(4 Week)
- Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom(2 Week)
- Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom(4 Week)
- Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom(8 Week)
- Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom(10 Week)
- Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function(2 Week)
- Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function(4 Week)
- Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function(8 Week)
- Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function(10 Week)
- Change in IBDQ Scores From Baseline to Weeks 8 - Social Function(8 Week)
- Change in IBDQ Scores From Baseline to Weeks 10 - Social Function(10 Week)