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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

Information source: S.L.A. Pharma AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Perianal Crohns'

Intervention: Metronidazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: S.L.A. Pharma AG

Official(s) and/or principal investigator(s):
Christopher J Jordan, BSC, Study Director, Affiliation: SLA Pharma

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Primary Purpose: Basic Science

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road, Harrow HA1 3UJ, United Kingdom
Additional Information

Starting date: October 2007
Last updated: October 16, 2008

Page last updated: August 23, 2015

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