NCT00774722已完成2 期
Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.
研究概览
简要总结
The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.
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
- •Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component)
- •Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement
- •Be medically fit for surgery
- •Subjects must be aged 18 years or over and of the legal age of consent.
- •If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study.
- •Must have provided written informed consent to participate.
排除标准
- •They have had surgery to the anus or rectum in the past 8 weeks
- •Suffer from a chronic pain syndrome which requires regular narcotic analgesia
- •Have anal fissures
- •Have diagnosed Crohn's disease
- •Allergic to metronidazole
- •Are taking any prohibited medication.
- •Deemed mentally incompetent
- •Considered by their physician unlikely to be able to comply with the protocol.
- •Taken part in an experimental drug study in the preceding three months.
研究组 & 干预措施
Metronidazole
Experimental
干预措施: Metronidazole (Drug)
Placebo
Placebo Comparator
干预措施: Metronidazole (Drug)
结局指标
主要结局
The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.
时间窗: 14 days
次要结局
- evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or(56 days)
研究者
研究点 (5)
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