A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal Application of Iferanserin (10 mg) as a 0.5% Ointment in Subjects With Symptomatic Internal Hemorrhoids
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 403
- 试验地点
- 76
- 主要终点
- Proportion of subjects with cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14) will be analyzed as the primary endpoint
研究概览
简要总结
Primary Objective:
To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids.
Methodology:
Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group, placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.
Study Treatment Duration:
Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12 months (open-label part of the study in which there will be a scheduled visit every three months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be treated with open-label iferanserin for 7 days followed by a 21-day follow-up period).
Criteria for Evaluation:
Primary Endpoint:
The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14).
详细描述
Primary Objective:
To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids. Safety Secondary Objective To determine the safety of iferanserin ointment administered intra-anally BID for 7 or 14 days in subjects with symptomatic internal hemorrhoids.
Exploratory Objectives:
To evaluate the frequency of recurrence of bleeding in subjects with symptomatic internal hemorrhoids. To evaluate time to bleeding recurrence in subjects with symptomatic internal hemorrhoids. To evaluate efficacy of iferanserin ointment in the treatment of recurrence when administered intra-anally BID for 7 days in subjects with symptomatic internal hemorrhoids. To evaluate the parameters of the Symptom Satisfaction Questionnaire
Methodology:
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iferanserin
干预措施: Iferanserin (Drug)
Placebo
干预措施: Placebo (Drug)
Iferanserin + Placebo
干预措施: Iferanserin + Placebo (Drug)
结局指标
主要结局
Proportion of subjects with cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14) will be analyzed as the primary endpoint
时间窗: 7 days
次要结局
- Proportion of subjects with cessation of pain by the end of Day 7 that persists for the remainder of the treatment period (through Day 14).(7 days)