A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
This study has been completed.
Sponsor:
S.L.A. Pharma AG
Information provided by:
S.L.A. Pharma AG
ClinicalTrials.gov Identifier:
NCT00774722
First received: October 16, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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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 ]
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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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
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
| 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: | October 16, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases Metronidazole |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013