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临床试验/EUCTR2005-001396-35-GB
EUCTR2005-001396-35-GB进行中(未招募)1 期

Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain after Haemorrhoidectomy - 10% Metronidazole ointment/Placebo after Haemorrhoidectomy

SLA Pharma (UK) Ltd0 个研究点目标入组 40 人开始时间: 2005年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

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.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 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.

研究者

发起方
SLA Pharma (UK) Ltd

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