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Completed

NCT Number: NCT00774722

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Sussex County Hospital, Eastern Road,, Brighton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metronidazole

Drug

10% ointment, three times daily for 14 days

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.

    Time frame: 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

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

S.L.A. Pharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2008
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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