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

S.L.A. Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Haemorrhoidectomy

Treatments: Drug: Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00774722

EudraCT Number 2005-001396-35

MET/02

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

Metronidazole

Experimental group

Treatment:

Drug: Metronidazole

Placebo

Placebo Comparator group

Treatment:

Drug: Metronidazole