A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 20
- 主要终点
- Active Phase: Proportion of Active Subjects Achieving Overall Improvement
研究概览
简要总结
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.
详细描述
A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.
Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.
- •Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
- •Infectious diseases, parasites, bacterial pathogens
- •Allergy to aspirin or salicylate
- •Liver or kidney abnormalities
- •Alcohol or drug abuse
- •Pregnancy
- •Bleeding disorders, ulcers, autoimmune diseases
- •Mental disorders
- •Participation in clinical trial in last 30 days
- •Inability to fill in diary cards / comply with protocol requirements
研究组 & 干预措施
Pentasa® modified extended release
5-ASA (5-Aminosalicylate)
干预措施: 5-ASA (5-Aminosalicylate) (Drug)
Pentasa®
5-ASA (5-Aminosalicylate)
干预措施: 5-ASA (5-Aminosalicylate) (Drug)
结局指标
主要结局
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
时间窗: From baseline to week 8
Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI). Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1. A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.
Maintenance Phase: Proportion of Subjects Experiencing Relapse
时间窗: Up to week 24
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
次要结局
- Frequency of Adverse Events(From baseline to week 24)