Status:
COMPLETED
A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
Lead Sponsor:
S.L.A. Pharma AG
Conditions:
Haemorrhoidectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00774722
Start Date
September 1 2006
End Date
March 1 2008
Last Update
June 5 2013
Active Locations (5)
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1
Royal Sussex County Hospital, Eastern Road,
Brighton, United Kingdom, BN2 5BE
2
St Marks Hospital
Harrow, United Kingdom, HA1 3UJ
3
North Middlesex University Hospital
London, United Kingdom, N18 1QX
4
St Thomas' Hospital, Lambeth Palace Road
London, United Kingdom, SE1 7EH