NCT01442363终止2 期
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Braintree Laboratories17 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 17
- 主要终点
- Percentage of Perianal Pain Responders
研究概览
简要总结
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must give written informed consent.
- •Male or female subjects, 18 years of age.
- •Confirmed diagnosis of Crohn's Disease.
- •Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and with clinical evidence of active PCD.
- •Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at Visit
- •Subjects must have a qualifying perianal pain score at Visits 1 and 2.
排除标准
- •Women of childbearing potential who are not using adequate contraception.
- •Women who are pregnant or breastfeeding.
- •Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF) inhibitors, immunosuppressants, steroids).
- •Subjects taking strong analgesics that could interfere with pain measurements. Subjects with a perianal abscess requiring incision and drainage.
- •Subjects with anal stenosis.
- •Subjects with fistulae outside the immediate perianal area.
- •Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.
- •Subjects who have had significant anorectal surgery for Crohns disease within the past 8 weeks.
研究组 & 干预措施
BLI-1300 (high dose)
Experimental
Investigational Product (20%) Ointment
干预措施: BLI-1300 high dose (Drug)
BLI-1300 (low dose)
Experimental
Investigational Product (10%) Ointment
干预措施: BLI-1300 low dose (Drug)
placebo
Placebo Comparator
Placebo Ointment
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Perianal Pain Responders
时间窗: 12 weeks
Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.
次要结局
未报告次要终点
研究者
研究点 (17)
Loading locations...
相似试验
已完成
2 期
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous AdministrationIgA NephropathyNCT02062684Anthera Pharmaceuticals57
已完成
3 期
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT01395745Anthera Pharmaceuticals442
已完成
1 期
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated VasculitisANCA-associated VasculitisNCT05197842Staidson (Beijing) Biopharmaceuticals Co., Ltd93
已完成
2 期
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne VulgarisAcne VulgarisNCT01815450Braintree Laboratories369
已完成
3 期
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)Coronary Artery DiseaseNCT00232765Cordis Corporation1,058