A Randomized. Double-blind, Placebo-controlled, Multi-national Study to Determine the Effect of Cellegesic Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With a Chronic Anal Fissure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 主要终点
- Change From Baseline in Pain Intensity at Days 14-18
研究概览
简要总结
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.
The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.
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
- •Consenting patients of either sex.
- •Between 18 and 75 years of age.
- •With a single, chronic, posterior midline anal fissure.
- •Defined as having anal pain for the 6 weeks prior to Screening.
排除标准
- •More than one anal fissure.
- •A fistula-in-ano or anal abscess.
- •Inflammatory bowel disease.
- •Fibrotic anal stenosis.
- •Anal fissure secondary to an underlying condition.
- •Any anal surgery.
- •Concomitant medication that may interfere with study evaluation.
研究组 & 干预措施
Cellegesic (nitroglycerin 0.4%)
Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
干预措施: Cellegesic (Drug)
Placebo 375 mg
Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Pain Intensity at Days 14-18
时间窗: Baseline to Day 18
Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.
次要结局
- Time to an Improvement in Pain Intensity(Baseline to Day 21)
- Percentage of Responders(Baseline to Day 18)