Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: S.L.A. Pharma AG
• Treatments: Metronidazole

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.