NCT00708656已完成3 期
A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.
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
- 213
- 试验地点
- 45
- 主要终点
- To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is equivalent to mesalazine (Asacol®) given as 800mg three times daily in preventing relapse over a 12 month period.
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.
详细描述
Study design
- Multicentre, randomized, single-blind, comparator-controlled, parallel-armed study
- One year follow-up, or until relapse (whichever shorter)
- 40-60 UK centres
Subject population
- Ulcerative colitis in remission (sigmoidoscopy score of 0 or 1 with no symptoms of active disease, with no treatment for active colitis) for at least 4 weeks, and for no more than 2 years
- Taking mesalazine or sulfasalazine prior to study entry
- Patients excluded if they have Crohn's disease, symptoms of active colitis, have used corticosteroids, ciclosporin or oral/enema mesalazine in the past 4 weeks, are intolerant to mesalazine or Asacol, are pregnant or lactating, or have known HIV, hepatic disease, renal impairment or other serious medical or psychiatric illness
- Sample size 250
- Gender: male or female
- Ethnicity: no restriction
- Age: over 18
Test Product
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria will be eligible for study entry:
- •Male and female patients aged over 18 with ulcerative colitis confirmed by histology who are in remission (no symptoms of active disease, and modified Baron sigmoidoscopic score of 0 or 1)
- •If female, must be (as documented in patient notes):
- •postmenopausal (at least 1 year without spontaneous menses), or
- •surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or
- •using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrollment, or
- •have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or
- •be using 1 barrier method (e.g., condom, diaphragm, spermicide, or intra-uterine device)
- •Patients whose ulcerative colitis has been in clinical remission for 4 weeks or longer, and who have had a symptomatic relapse within the past two years
- •Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer
- •Patients capable of giving written informed consent
排除标准
- •The following patients will be excluded from the study:
- •Patients with Crohn's disease
- •Patients with symptoms of active colitis
- •Modified Baron sigmoidoscopy score of 2 or 3
- •Patients who have used oral, enema, intravenous or suppository preparations of corticosteroids, oral or intravenous ciclosporin, mesalazine enemas or suppositories within the past four weeks
- •Patients taking azathioprine or 6-mercaptopurine who have altered the dose or started treatment within the past three months, (these drugs permitted in stable dose during the study)
- •Patients with intolerance to Asacol 400 mg or mesalazine
- •Women who are pregnant or lactating
- •Patients with known HIV infection
- •Patients with hepatic disease
- •Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein
- •Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study
- •Patients with problem alcohol excess or drug abuse
研究组 & 干预措施
2: tds
Active Comparator
Mesalazine (Asacol®) 800mg given three times daily
干预措施: mesalazine (Asacol®) (Drug)
1: once daily
Experimental
Three 800mg tablets of mesalazine (Asacol®) in the morning
干预措施: mesalazine (Asacol®) (Drug)
结局指标
主要结局
To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is equivalent to mesalazine (Asacol®) given as 800mg three times daily in preventing relapse over a 12 month period.
时间窗: At relapse or 12 month follow up
次要结局
- To assess equivalence in terms of safety(12 months)
- To assess equivalence in terms of time to relapse(12 months)
- To assess equivalence in terms of progression of disease (measured by Mayo score)(12 months)
研究者
研究点 (45)
Loading locations...
相似试验
终止
3 期
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of DiverticulitisDiverticulitisNCT00695643Dr. Falk Pharma GmbH345
终止
3 期
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of DiverticulitisDiverticulitisNCT01038739Dr. Falk Pharma GmbH330
已完成
2 期
Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar DepressionBipolar DepressionNCT01586793Douglas Mental Health University Institute8
已完成
2 期
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's DiseaseAlzheimer DiseaseNCT06538116Eli Lilly and Company304
已完成
早期 1 期
A Clinical Study Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemiaBeta-ThalassemiaNCT06024876CorrectSequence Therapeutics Co., Ltd5