Clarithromycin in Active Crohn's Disease - Full Text View

Sponsor:	Royal Liverpool University Hospital
Collaborator:	Abbott
Information provided by:	Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:	NCT00269386

Purpose

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:	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:

Genetics Home Reference related topics: Crohn disease

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

Show Detailed Description

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

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 February 09, 2012