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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

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ClinicalTrials.gov Identifier: NCT00774969
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
S.L.A. Pharma AG

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.

Condition or disease Intervention/treatment Phase
Perianal Crohns' Drug: Metronidazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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





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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00774969     History of Changes
Other Study ID Numbers: MET/PK/01
EudraCT/IND 2007003173-68
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents