NCT03412682已完成3 期
A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 72
- 主要终点
- Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
研究概览
简要总结
To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
- •Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
- •Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
- •Male patients must agree to use medically approved contraception throughout the trial period.
排除标准
- •Patients with limited distal proctitis.
- •Patients with infectious colitis.
- •Patients with history of colectomy.
- •Patients with severe diseases in other organs and systems.
- •Evidence or history of toxic megacolon.
- •Women who wish to become pregnant during the trial period
研究组 & 干预措施
Budesonide (6 mg)
Experimental
干预措施: Budesonide (6 mg) (Drug)
Budesonide (9 mg)
Experimental
干预措施: Budesonide (9 mg) (Drug)
Mesalazine (3,600 mg)
Active Comparator
干预措施: Mesalazine (3,600 mg) (Drug)
结局指标
主要结局
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
时间窗: After 8 weeks
UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity.
次要结局
- Percentage of subjects achieving clinical remission after 8 weeks of treatment(8 weeks)
- Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment(8 weeks)
- Percentage of subjects achieving clinical improvement after 8 weeks of treatment(8 weeks)
- Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1(8 weeks)
- Change from baseline in partial UCDAI score at 8 weeks(8 weeks)
- Percentage of subjects achieving symptom resolution after 2 weeks of treatment(2 weeks)
- Percentage of subjects achieving symptom resolution after 4 weeks of treatment(4 weeks)
- Percentage of subjects achieving symptom resolution after 8 weeks of treatment(8 weeks)
- Percentage of subjects with endoscopic healing after 8 weeks of treatment(8 weeks)
- Change from baseline in partial UCDAI score at 2 weeks(2 weeks)
- Change from baseline in partial UCDAI score at 4 weeks(4 weeks)
研究者
研究点 (72)
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