Post-Haemorrhoidectomy Pain
Conditions
Interventions
Product Name: Metronidazole 10% Ointment
Product Code: MET
Pharmaceutical Form: Ointment
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
SLA Pharma (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion 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. 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 10% metronidazole ointment, applied topically TID in and around the anus, on the reduction of pain following haemorrhoidectomy.;Secondary Objective: To evaluate and compare the relief of perianal pain following haemorrhoidectomy, against placebo. To evaluate and compare the experienced pain vs expected pain following haemorrhoidectomy in the treatment and placebo groups. To evaluate and compare overall patient satisfaction with the operation To evaluate and compare the number of analgesics required post-operatively by the treatment and placebo group To compare the time taken to return to work and/or normal activities. To determine the safety and tolerability of 10% metronidazole applied topically TID in and around the anus;Primary end point(s): The difference in pain reduction between patients using 10% metronidazole ointment and those using placebo ointment post-haemorrhoidectomy | — |
Countries
United Kingdom
Outcome results
None listed