Status:
COMPLETED
Clarithromycin in Active Crohn's Disease
Lead Sponsor:
Royal Liverpool University Hospital
Collaborating Sponsors:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Clarithromycin may be an effective therapy in Crohn's disease. It is a broad spectrum antibiotic. Crohn's disease, the investigators think, is in some way related to bacteria, which reside in the bowe...
Detailed Description
WHAT IS THE PROBLEM TO BE ADDRESSED ? Lack of effective cure for Crohn's disease. Effective symptomatic treatment of Crohn's disease can be achieved in approximately 60-80% using corticosteroids \[1...
Eligibility Criteria
Inclusion
- Patients with Crohn's disease diagnosed by conventional clinical, radiological and histological criteria.
- Active Crohn's disease: Crohn's Disease Activity Index (CDAI)\> 200 and CRP \> 10 mg/l.
- Patients on 10mg or less of prednisolone or 3mg budesonide.
- Patients on a stable dose of azathioprine for at least 3 months and on stable dose of 5-ASA preparation for at least one month.
Exclusion
- Patients under 18 or unable to give informed consent.
- Patients on long term antibiotics for Crohn's disease or other indications
- Known sensitivity to clarithromycin
- Pregnant, post partum (\<3months) or breast feeding females.
- Any change to medication for Crohn's disease for previous month.
- Patients with complications requiring surgery (significant intestinal obstruction, perforation or abscess)
- CDAI \> 450
- Participation in other trials in the last 3 months.
- Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease)
- Patients on cisapride, astemizole or terfenadine (prolonged QT interval and arrhythmias reported with macrolide antibiotics)
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00269386
Start Date
April 1 2000
End Date
May 1 2007
Last Update
January 7 2009
Active Locations (1)
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1
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP