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

This study has been completed.
Information provided by (Responsible Party):
S.L.A. Pharma AG Identifier:
First received: October 16, 2008
Last updated: June 4, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Haemorrhoidectomy Drug: Metronidazole Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy

Resource links provided by NLM:

Further study details as provided by S.L.A. Pharma AG:

Primary Outcome Measures:
  • The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo. [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 56 days ]

Enrollment: 59
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole Drug: Metronidazole
10% ointment, three times daily for 14 days
Placebo Comparator: Placebo Drug: Metronidazole
10% ointment, three times daily for 14 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00774722

United Kingdom
Royal Sussex County Hospital, Eastern Road,
Brighton, United Kingdom, BN2 5BE
St Marks Hospital
Harrow, United Kingdom, HA1 3UJ
North Middlesex University Hospital
London, United Kingdom, N18 1QX
St Thomas' Hospital, Lambeth Palace Road
London, United Kingdom, SE1 7EH
Stepping Hill Hospital
Stockport, United Kingdom, SK2 7JE
Sponsors and Collaborators
S.L.A. Pharma AG
Study Director: Christopher J Jordan, BSc SLA Pharma
  More Information

Responsible Party: S.L.A. Pharma AG Identifier: NCT00774722     History of Changes
Other Study ID Numbers: MET/02
EudraCT Number 2005-001396-35
Study First Received: October 16, 2008
Last Updated: June 4, 2013

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on September 18, 2017