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

This study has been completed.
Sponsor:
Information provided by:
S.L.A. Pharma AG
ClinicalTrials.gov Identifier:
NCT00774969
First received: October 16, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by S.L.A. Pharma AG:

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
Experimental: All
6 patients with Perianal Crohn's Disease and 10 healthy Volunteers
Drug: Metronidazole
Metronidazole 10% ointment three times a day 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774969

Locations
United Kingdom
Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
S.L.A. Pharma AG
Investigators
Study Director: Christopher J Jordan, BSC SLA Pharma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00774969     History of Changes
Other Study ID Numbers: MET/PK/01, EudraCT/IND 2007003173-68
Study First Received: October 16, 2008
Last Updated: October 16, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014