evaluation of the pharmacokinetics of metronidazole 10% ointment applied peri anally in healthy volunteers and patients with perianal crohn's disease

Conditions: Perianal Crohns'

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 criteria: 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 criteria: 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.