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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG
ClinicalTrials.gov Identifier:
NCT00774722
First received: October 16, 2008
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774722

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

No publications provided

Responsible Party: S.L.A. Pharma AG
ClinicalTrials.gov 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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014