Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Primary Purpose
Perianal Crohns'
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Metronidazole
Sponsored by
About this trial
This is an interventional basic science trial for Perianal Crohns'
Eligibility 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.
Sites / Locations
- Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All
Arm Description
6 patients with Perianal Crohn's Disease and 10 healthy Volunteers
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00774969
Brief Title
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
S.L.A. Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Crohns'
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All
Arm Type
Experimental
Arm Description
6 patients with Perianal Crohn's Disease and 10 healthy Volunteers
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Metronidazole 10% ointment three times a day 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Jordan, BSC
Organizational Affiliation
SLA Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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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