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

Haemorrhoidectomy Clinical Trial

Official title:

Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774722
• Other study ID #: MET/02
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 16, 2008
• Last updated: June 4, 2013
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: June 2013
• Source: S.L.A. Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemorrhoidectomy

Intervention

Drug:
• Metronidazole
10% ointment, three times daily for 14 days

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital, Eastern Road,	Brighton
United Kingdom	St Marks Hospital	Harrow
United Kingdom	North Middlesex University Hospital	London
United Kingdom	St Thomas' Hospital, Lambeth Palace Road	London
United Kingdom	Stepping Hill Hospital	Stockport

Sponsors (1)

Lead Sponsor	Collaborator
S.L.A. Pharma AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.		14 days	No
Secondary	evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or		56 days	No