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Sponsored by: |
S.L.A. Pharma AG |
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Information provided by: | S.L.A. Pharma AG |
ClinicalTrials.gov Identifier: | NCT00774969 |
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.
Condition | Intervention | Phase |
---|---|---|
Perianal Crohns' |
Drug: Metronidazole |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Single Group Assignment |
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 |
Enrollment: | 19 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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All: Experimental
6 patients with Perianal Crohn's Disease and 10 healthy Volunteers
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Drug: Metronidazole
Metronidazole 10% ointment three times a day 7 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patient group:
Subjects can be on concomitant medication. Acceptable regimens are:
Healthy volunteer group:
Exclusion Criteria:
Patient group:
Healthy volunteer group:
United Kingdom | |
Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road | |
Harrow, United Kingdom, HA1 3UJ |
Study Director: | Christopher J Jordan, BSC | SLA Pharma |
Study ID Numbers: | MET/PK/01, EudraCT/IND 2007003173-68 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774969 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Metronidazole Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Healthy Gastroenteritis Intestinal Diseases |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Radiation-Sensitizing Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |