Clinical trial NCT00774969: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Perianal Crohns'
Lead sponsor: S.L.A. Pharma AG
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Sainsbury Wing, St Marks & Northwick Park Hospitals, Watford Road
Study officials:
affiliation: SLA Pharma
name: Christopher J Jordan, BSC
role: STUDY_DIRECTOR
References: