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CompletedNCT00774722Updated Jun 5, 2013

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

A Phase 2/3 interventional study of Metronidazole in Haemorrhoidectomy, sponsored by S.L.A. Pharma AG. Completed at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by S.L.A. Pharma AG · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Haemorrhoidectomy
03

In context

Lead sponsor

S.L.A. Pharma AG is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Metronidazole

    Drug: Metronidazole

  • Placebo comparator
    Placebo

    Drug: Metronidazole

Interventions

  • DrugMetronidazole

    10% ointment, three times daily for 14 days

06

What researchers measure

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

07

Study locations

5 sites
  • Royal Sussex County Hospital, Eastern Road,
    Brighton, BN2 5BE, United Kingdom
  • St Marks Hospital
    Harrow, HA1 3UJ, United Kingdom
  • North Middlesex University Hospital
    London, N18 1QX, United Kingdom
  • St Thomas' Hospital, Lambeth Palace Road
    London, SE1 7EH, United Kingdom
  • Stepping Hill Hospital
    Stockport, SK2 7JE, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00774722
Lead sponsor
S.L.A. Pharma AG
Responsible party
Sponsor
First posted
Oct 17, 2008
Start date
Sep 2006
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Jun 5, 2013

Study contacts

Christopher J Jordan, BSc
study director · SLA Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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