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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014