A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 90
- 主要终点
- Proportion of Subjects With Remission
研究概览
简要总结
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects aged 18 to 75 years
- •Mild to moderate UC
排除标准
- •Disease limited to proctitis <15 cm
- •Short bowel syndrome
- •Prior colon resection surgery
- •History of severe/fulminant UC
- •Evidence of other forms of inflammatory bowel disease
- •Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
- •Intolerant or allergic to aspirin or salicylate derivatives
- •Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
- •Women who are pregnant or nursing
- •History or known malignancy
- •History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
研究组 & 干预措施
Mesalamine
4 g extended release granules (sachet)
干预措施: Mesalamine (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Subjects With Remission
时间窗: At Week 8
The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).
次要结局
- The Proportion of Subjects With Endoscopic Improvement(At Week 8)
- Time to Normal Stool Pattern(Up to Week 8)
- The Change From Baseline in Fecal Calprotectin Levels at Week 8(From baseline to Week 8)
- The Change From Baseline in Health Related Quality of Life (QoL) Scores(From baseline to Week 2, 4, and 8)
- Proportion of Subjects With Abnormal Laboratory Values (Coagulation)(Up to Week 16)
- The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8(From baseline to Week 2, 4, and 8)
- Proportion of Subject With Abnormal Laboratory Values (Hematology)(Up to Week 16)
- Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)(Up to Week 16)
- The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8(From baseline to Week 2, 4, and 8)
- Time to Cessation of Rectal Bleeding(Up to Week 8)
- The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8(At Week 2, 4, and 8)
- Number of Participants Experiencing Adverse Events(Up to Week 16)
- Severity of Adverse Events(Up to Week 16)
- Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)(At Week 8)