A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S.L.A. Pharma AG
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.