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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00774722
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Haemorrhoidectomy Drug: Metronidazole Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774722


Locations
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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
Investigators
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Study Director: Christopher J Jordan, BSc SLA Pharma
More Information
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Responsible Party: S.L.A. Pharma AG
ClinicalTrials.gov Identifier: NCT00774722    
Other Study ID Numbers: MET/02
EudraCT Number 2005-001396-35
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents