A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- Bleeding / Spotting
研究概览
简要总结
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).
Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region.
At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage.
Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bleeding hemorrhoids with / without pain
- •Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
- •Signed Informed Consent
排除标准
- •Known rectal sensitivity
- •Rectal infection
- •Grade IV hemorrhoids
- •Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
- •Known inflammatory bowel disease
- •Anal fissure
- •Military personnel
- •Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing
- •Patients who have been involved in another experimental trial within the past 30 days
- •Patients presently diagnosed with cancer
研究组 & 干预措施
PP110 Gel
PP110 Gel
干预措施: PP110 Gel (Drug)
PP110 medicated wipes
PP110 Medicated wipes
干预措施: PP110 Medicated wipes (Drug)
Preparation-H cream
Preparation-H cream
干预措施: Preparation-H Cream (Drug)
结局指标
主要结局
Bleeding / Spotting
时间窗: 14 days
次要结局
- Pain(14 days)
- Discharge(14 days)
- Itching(14 days)
- Swelling(14 days)
- Discomfort(14 days)
- Painkillers usage(14 days)