NCT00269386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

Enrollment Period

6.7 years

First QC Date

December 22, 2005

Last Update Submit

January 6, 2009

Conditions

Crohn's Disease

Keywords

ClarithromycinCrohn's

Outcome Measures

Primary Outcomes (1)

  • Remission defined as a CDAI<150 and response defined as a fall in CDAI by more than 70 points from pretreatment level.

    2 months

Secondary Outcomes (4)

  • Fall in Van Hees activity index

    2 months

  • Improvement in Inflammatory Bowel Disease specific Quality of Life Index

    2 months

  • Reduction of serum CRP.

    2 months

  • Withdrawal: Rise in CDAI>50 points from baseline

    any time during trial

Study Arms (2)

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

2 (ii)

PLACEBO COMPARATOR

placebo tablets of identical size, colour and taste

Drug: Placebo

Interventions

ClarithromycinDRUG

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

Also known as: Clarithromycin S/R (Klaricid XL)
1 (i)
PlaceboDRUG
2 (ii)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jonathan M Rhodes, MD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

April 1, 2000

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

GB(1)