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Clarithromycin in Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269386
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : January 7, 2009
Information provided by:
Royal Liverpool University Hospital

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 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 or disease Intervention/treatment Phase
Crohn's Disease Drug: Clarithromycin Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Clarithromycin in Active Crohn's Disease
Study Start Date : April 2000
Primary Completion Date : December 2006
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Fall in Van Hees activity index [ Time Frame: 2 months ]
  2. Improvement in Inflammatory Bowel Disease specific Quality of Life Index [ Time Frame: 2 months ]
  3. Reduction of serum CRP. [ Time Frame: 2 months ]
  4. Withdrawal: Rise in CDAI>50 points from baseline [ Time Frame: any time during trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269386

United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP
Sponsors and Collaborators
Royal Liverpool University Hospital
Principal Investigator: Jonathan M Rhodes, MD University of Liverpool

Responsible Party: Professor J M Rhodes, Department of Medicine, Duncan Building, Daulby Street, Liverpool, L69 3GA Identifier: NCT00269386     History of Changes
Other Study ID Numbers: RLBUHT R&D 1558
ACA-GBNI-98-090 (Abbott ref)
DDX MRHA ref MF8000/9193
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by Royal Liverpool University Hospital:

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors