HaemorrhoidectomyPhase 2/3NCT00774722
A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
A Phase 2/3 study testing Metronidazole in people with Haemorrhoidectomy, run by S.L.A. Pharma AG at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoidectomy
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2006to Mar 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Royal Sussex County Hospital, Eastern Road,
Brighton, BN2 5BE
St Marks Hospital
Harrow, HA1 3UJ
North Middlesex University Hospital
London, N18 1QX
St Thomas' Hospital, Lambeth Palace Road
London, SE1 7EH
Stepping Hill Hospital
Stockport, SK2 7JE
About this study
Official title: Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy
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.
- Conditions
- Haemorrhoidectomy
- Being tested
- Metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
10% ointment, three times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Not described Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Not described Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.
Measured: 14 days
Secondary outcomes (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
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher J Jordan, BSc, Study director, SLA Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774722
- Sponsor's protocol ID
- MET/02
- Other IDs
- EudraCT Number 2005-001396-35
- Status last verified
- Jun 2013
- First submitted
- 16 Oct 2008
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy
- ClinicalTrials.gov ID
- NCT00774722
- Acronym / sponsor ID
- MET/02
- Conditions
- Haemorrhoidectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: Metronidazole |
| Placebo | Placebo comparator | Drug: Metronidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole10% ointment, three times daily for 14 days | Drug | Metronidazole, Placebo |
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.
Time frame: 14 days
1 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
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Jordan, BSc study director
SLA Pharma
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metronidazole in people with Haemorrhoidectomy, run by S.L.A. Pharma AG at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.