Status:
COMPLETED
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Lead Sponsor:
S.L.A. Pharma AG
Conditions:
Perianal Crohns'
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00774969
Start Date
October 1 2007
End Date
April 1 2008
Last Update
October 17 2008
Active Locations (1)
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1
Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
Harrow, United Kingdom, HA1 3UJ