DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017