Clarithromycin in Active Crohn's Disease
This study has been completed.
Sponsor:
Royal Liverpool University Hospital
Collaborator:
Abbott
Information provided by:
Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:
NCT00269386
First received: December 22, 2005
Last updated: January 6, 2009
Last verified: January 2009
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Purpose
Show Detailed Description
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 bowel.
Previous studies of different types of antibiotic in Crohn's disease have shown encouraging results. Clarithromycin alters the bacteria in the bowel and gets into cells in the bowel which may contain bacteria. There is some evidence that clarithromycin can stimulate the immune system and improve the function of cells involved in killing bacteria in the bowel.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: Clarithromycin Drug: Placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | Randomised Controlled Trial of Clarithromycin in Active Crohn's Disease |
Resource links provided by NLM:
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Clarithromycin
U.S. FDA Resources
Further study details as provided by Royal Liverpool University Hospital:
Primary Outcome Measures:
- Remission defined as a CDAI<150 and response defined as a fall in CDAI by more than 70 points from pretreatment level. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Fall in Van Hees activity index [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Improvement in Inflammatory Bowel Disease specific Quality of Life Index [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Reduction of serum CRP. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Withdrawal: Rise in CDAI>50 points from baseline [ Time Frame: any time during trial ] [ Designated as safety issue: Yes ]
Enrollment: | 44 |
Study Start Date: | April 2000 |
Study Completion Date: | May 2007 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1 (i)
Clarithromycin S/R 1g od From April 2004, clarithromycin S/R (Klaricid XL) ceased to be available and subsequent patients will receive either standard clarithromycin 500mg bd or placebo tables of identical size, colour and taste
|
Drug: Clarithromycin
Clarithromycin S/R 1g once daily April 2004 - Clarithromycin S/R (Klaricid XL) ceased to be abailable and subsequent patients will receive standard Clarithromycin 500mg bd
Other Name: Clarithromycin S/R (Klaricid XL)
|
Placebo Comparator: 2 (ii)
placebo tablets of identical size, colour and taste
|
Drug: Placebo |
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Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269386
Locations
United Kingdom | |
Royal Liverpool University Hospital | |
Liverpool, Merseyside, United Kingdom, L7 8XP |
Sponsors and Collaborators
Royal Liverpool University Hospital
Abbott
Investigators
Principal Investigator: | Jonathan M Rhodes, MD | University of Liverpool |
More Information
No publications provided
Keywords provided by Royal Liverpool University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | Professor J M Rhodes, Department of Medicine, Duncan Building, Daulby Street, Liverpool, L69 3GA |
ClinicalTrials.gov Identifier: | NCT00269386 History of Changes |
Other Study ID Numbers: | RLBUHT R&D 1558, ACA-GBNI-98-090 (Abbott ref), DDX MRHA ref MF8000/9193 |
Study First Received: | December 22, 2005 |
Last Updated: | January 6, 2009 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Royal Liverpool University Hospital:
Clarithromycin Crohn's |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Clarithromycin |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012