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

COMPLETEDPHASE1

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

Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease

NCT00774969•S.L.A. Pharma AG

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+14 more criteria

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.
+13 more criteria

Locations (1)

Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road

Harrow, United Kingdom

Key Dates

Start Date

October 1, 2007

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

October 17, 2008

Enrollment

ACTUAL participants

Conditions

Perianal Crohns'

Interventions

Metronidazole

DRUG