Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- calculation of medication consumption rates at months 3, 6, 9 and 12
研究概览
简要总结
The purpose of this study is to determine if taking Asacol once a day is as effective as taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is experimental, and has not been approved by the FDA. Dosing as three times daily is FDA approved.
This research is being done because the researchers want to learn what the best methods are for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to subjects in continuing to take a medication to control their ulcerative colitis.
详细描述
Hypothesis: Asacol taken once a day is equally effective (non-inferior) as conventional (twice or three times a day) dosing at maintaining remission in quiescent ulcerative colitis.
Specific Aims:
- To assess the efficacy of once daily Asacol in the short and long-term maintenance of remission in quiescent ulcerative colitis.
- To assess the medication consumption rate (adherence) in patients prescribed once daily Asacol compared to a bid or tid regimen.
Background:
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine characterized by episodes of relapse and remission. Relapses are often not predictable, although factors such as smoking cessation, chronic non-steroidal antiinflammatory use and psychological stress are thought to cause symptom exacerbation in some individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
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
- •Adult patients over the age of 18 followed at the University of Chicago Outpatient Gastroenterology Clinic will be eligible. Patients must have documentation of ulcerative colitis by standard criteria, and be in remission for at least 4 months prior to study entry. Remission for this study will be defined clinically, as the absence of all of the following: blood in the stools, urgency, or cramping. Patients must be taking a regimen of Asacol (Asacol, Procter and Gamble, Cincinnati Ohio) for maintenance of quiescent disease
排除标准
- •Exclusion criteria include documented disease activity in the past four months, hospitalization or steroid use for disease activity in the previous 4 months, or the use of other immunomodulators to induce remission. Patients with a history of other diarrheal illnesses such as diarrhea-predominant Irritable Bowel Syndrome, C difficile colitis, use of known diarrheal drugs will also be excluded.
结局指标
主要结局
calculation of medication consumption rates at months 3, 6, 9 and 12
disease relapse
12-month study period
次要结局
未报告次要终点