Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Royal Liverpool University Hospital Abbott |
---|---|
Information provided by: | Royal Liverpool University Hospital |
ClinicalTrials.gov Identifier: | NCT00269386 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised Controlled Trial of Clarithromycin in Active Crohn's Disease |
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 |
---|---|
1 (i): Active Comparator
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
|
2 (ii): Placebo Comparator
placebo tablets of identical size, colour and taste
|
Drug: Placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Merseyside | |
Royal Liverpool University Hospital | |
Liverpool, Merseyside, United Kingdom, L7 8XP |
Principal Investigator: | Jonathan M Rhodes, MD | University of Liverpool |
Responsible Party: | Department of Medicine, Duncan Building, Daulby Street, Liverpool, L69 3GA ( Professor J M Rhodes ) |
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 |
ClinicalTrials.gov Identifier: | NCT00269386 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Clarithromycin Crohn's |
Clarithromycin Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |