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

NCT00774969 | Completed Phase 1 DMC

• 2 other identifiers: MET/PK/01EudraCT/IND 2007003173-68
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perianal Crohns'

Study Arms (1)

All

EXPERIMENTAL

6 patients with Perianal Crohn's Disease and 10 healthy Volunteers

Drug: Metronidazole

Interventions

Metronidazole DRUG

Metronidazole 10% ointment three times a day 7 days

All

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (1)

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

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christopher J Jordan, BSC

  SLA Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

GB (1)