Perianal Crohns'Phase 1NCT00774969
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
A Phase 1 study testing Metronidazole in people with Perianal Crohns', run by S.L.A. Pharma AG at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perianal Crohns'
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Apr 2008
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient group:
- Male and female patients with Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- Aged 18-65 years.
- Have had perianal symptoms for longer than 2 months
- Have a score of 5 or above in the Perianal Crohn's Disease Activity Index (PCDAI)
- Have a score of 1 or above on the 'Type of perianal disease' assessment of the PCDAI
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- Subjects can be on concomitant medication. Acceptable regimens are:
- Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;Infliximab on a stable infusion regimen;
- Oral corticosteroids <40mg per day; Methotrexate, provided that dosage has been stable for more than 4 weeks; azathioprine or mercaptopurine at a dosage that has been stable for more than 8 weeks;
- Antibiotics at a dosage that has been stable for 4 weeks but excluding metronidazole.
- Cyclosporin on a stable dose for more than 4 weeks.
- If patients have setons these must have been in place for at least 4 weeks prior to screening.
- 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 double-barrier methods of contraception (two separate methods of birth control, one of which may include oral contraception) for the duration of the study.
- Must have provided written informed consent to participate.
- Healthy volunteer group:
- They have had surgery to the anus or rectum in the past 4 weeks.
- Have a history of inflammatory bowel disease.
- Allergic to metronidazole.
- Are taking any prohibited medication.
- Not prepared to refrain from drinking alcohol during the course of the study.
- Deemed mentally incompetent.
- Considered by their physician unlikely to be able to comply with the protocol.
- Has donated blood within the past 3 months.
- Taken part in an experimental drug study in the preceding three months.
Who cannot join
- Patient group:
- They have had surgery to the anus or rectum in the past 4 weeks.
- They have a perianal abscess requiring incision and drainage.
- They have a stoma of less than 6 months duration.
- Allergic to metronidazole.
- Are taking any prohibited medication.
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- Not prepared to refrain from drinking alcohol during the course of the study.
- Deemed mentally incompetent.
- Considered by their physician unlikely to be able to comply with the protocol.
- Has donated blood within the past 3 months.
- Taken part in an experimental drug study in the preceding three months.
- Has donated blood within the past 3 months.
- Taken part in an experimental drug study in the preceding three months.
- Healthy volunteer group:
- They have had surgery to the anus or rectum in the past 4 weeks.
- Have a history of inflammatory bowel disease.
- Allergic to metronidazole.
- Are taking any prohibited medication.
- Not prepared to refrain from drinking alcohol during the course of the study.
- Deemed mentally incompetent.
- Considered by their physician unlikely to be able to comply with the protocol.
- Has donated blood within the past 3 months.
- Taken part in an experimental drug study in the preceding three months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
Harrow, HA1 3UJ
About this study
Official title: Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
The purpose of this study is to evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application.
- Conditions
- Perianal Crohns'
- Being tested
- Metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Metronidazole 10% ointment three times a day 7 days
| Study group | Role | What they receive |
|---|---|---|
| All | Experimental | 6 patients with Perianal Crohn's Disease and 10 healthy Volunteers Receives: Drug: Metronidazole |
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 startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal Crohns'Studies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher J Jordan, BSC, Study director, SLA Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774969
- Sponsor's protocol ID
- MET/PK/01
- Other IDs
- EudraCT/IND 2007003173-68
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
- ClinicalTrials.gov ID
- NCT00774969
- Acronym / sponsor ID
- MET/PK/01
- Conditions
- Perianal Crohns'
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 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 evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | Experimental | Drug: Metronidazole6 patients with Perianal Crohn's Disease and 10 healthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male and female patients with Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- Aged 18-65 years.
- Have had perianal symptoms for longer than 2 months
- Have a score of 5 or above in the Perianal Crohn's Disease Activity Index (PCDAI)
- Have a score of 1 or above on the 'Type of perianal disease' assessment of the PCDAI
Key exclusion criteria (23 listed)
- They have had surgery to the anus or rectum in the past 4 weeks.
- They have a perianal abscess requiring incision and drainage.
- They have a stoma of less than 6 months duration.
- Allergic to metronidazole.
- Are taking any prohibited medication.
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 |
|---|---|---|
| MetronidazoleMetronidazole 10% ointment three times a day 7 days | Drug | All |
Primary outcome
Not reported in the source record.
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 17 Oct 2008.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metronidazole in people with Perianal Crohns', run by S.L.A. Pharma AG at 1 site 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 24 inclusion and 23 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 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 17 Oct 2008.