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

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.

Study Overview

• Status: Completed
• Conditions: Perianal Crohns'
• Intervention / Treatment: Drug: Metronidazole

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All; 6 patients with Perianal Crohn's Disease and 10 healthy Volunteers	Drug: Metronidazole; Metronidazole 10% ointment three times a day 7 days

Collaborators and Investigators

• Sponsor: S.L.A. Pharma AG
• Investigators: Study Director: Christopher J Jordan, BSc, SLA Pharma

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2008
• Last Update Submitted That Met QC Criteria: October 16, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: MET/PK/01; EudraCT/IND 2007003173-68