A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
Information source: S.L.A. Pharma AG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemorrhoidectomy
Intervention: Metronidazole (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: S.L.A. Pharma AG Official(s) and/or principal investigator(s): Christopher J Jordan, BSc, Study Director, Affiliation: SLA Pharma
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.
Clinical Details
Official title: Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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
Additional Information
Starting date: September 2006
Last updated: June 4, 2013
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