Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain after Haemorrhoidectomy - 10% Metronidazole ointment/Placebo after Haemorrhoidectomy
- Conditions
- Post-Haemorrhoidectomy Pain
- Registration Number
- EUCTR2005-001396-35-GB
- Lead Sponsor
- SLA Pharma (UK) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method