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

NCT00774722 | Completed Phase 2

• 2 other identifiers: MET/02EudraCT Number 2005-001396-35
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 5

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.

Conditions

Haemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Metronidazole

EXPERIMENTAL

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Drug: Metronidazole

Interventions

Metronidazole DRUG

10% ointment, three times daily for 14 days

Metronidazole; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (5)

Royal Sussex County Hospital, Eastern Road,

Brighton, BN2 5BE, United Kingdom

Location

St Marks Hospital

Harrow, HA1 3UJ, United Kingdom

Location

North Middlesex University Hospital

London, N18 1QX, United Kingdom

Location

St Thomas' Hospital, Lambeth Palace Road

London, SE1 7EH, United Kingdom

Location

Stepping Hill Hospital

Stockport, SK2 7JE, United Kingdom

Location

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christopher J Jordan, BSc

  SLA Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: September 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

GB (5)