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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	1 February 2020
Main ID:	EUCTR2008-001137-99-GB
Date of registration:	27/11/2008
Prospective Registration:	Yes
Primary sponsor:	Royal Liverpool & Broadgreen University Hospitals Trust
Public title:	CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease
Scientific title:	CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease
Date of first enrolment:	28/04/2009
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001137-99
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria
(i) Patient is willing to participate in the study and has signed the informed consent
(ii) Patients aged 18 or over with Crohn’s disease diagnosed by conventional clinical, radiological and histological criteria.
(iii) Crohn’s disease involving small bowel, colon or both.
(iv) Active Crohn’s disease: Crohn’s Disease Activity Index (CDAI)> 200 and CRP>10mg/l.
(v) Patients receiving mesalazine (5ASA) must have had a stable dose for at least one month.
(vi) Patients receiving azathioprine or 6-mercaptopurine (who will be separately stratified) must have had a stable dose for at least 3 months.
(vii) Women of child bearing potential must have a negative urine pregnancy test prior to the start of study medication

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
Exclusion Criteria
(i) Patients under 18 or unable to give informed consent.
(ii) Any antibiotic use within the previous 4 weeks
(iii) Know sensitivity to Ciprofloxacin, Doxycyclineor Budesonide
(iv) Patients with a history of tendon disorders related to fluroquinoline administration
(v) Any change to immunosuppressive therapy (azathioprine, 6-mercaptopurine or methotrexate) within the previous 3 months.
(vi) Use of infliximab or adalimumab (anti-TNF antibody) within the previous 3 months
(vii) Concurrent use of systemic corticosteroids in excess of oral prednisolone 5 mgs/day or budesonide 3mg/day)
(viii) Any change to medication for Crohn’s disease in previous 4 weeks.
(ix) Patients with complications requiring surgery (significant intestinal obstruction, perforation or abscess)
(x) CDAI >450
(xi) Participation in other trials in the last 3 months.
(xii) Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease)
(xiii) Pregnant, post partum (<3months) or breast feeding females
(xiv) Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period (double barrier methods such as condoms or diaphragms with spermicidal gel or foam), and for up to 4 weeks after the study
(xv) Patients who need to continue to receive oral contraceptives (if unwilling to use double barrier methods), oral anticoagulants tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, sucralfate, cyclosporine.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: Ciprofloxacin
Product Code: PL 20532/0012
Pharmaceutical Form: Tablet
INN or Proposed INN: Ciprofloxacin hydrochloride
CAS Number: 86393-32-0
Current Sponsor code: 3591
Concentration unit: mg milligram(s)
Concentration type: not less then

Product Name: Budesonide
Product Code: PL 17901/0122
Pharmaceutical Form: Capsule
INN or Proposed INN: Budesonide
Current Sponsor code: 3591
Other descriptive name: Entocort CR
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 9-3

Trade Name: DOXYCYCLINE
Product Name: DOXYCYCLINE
Pharmaceutical Form: Tablet
INN or Proposed INN: DOXYCYCLINE HYCLATE
CAS Number: 564-25-0
Current Sponsor code: 3591
Other descriptive name: DOXYCYCLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-200

Trade Name: HYDROXYCHLOROQUINE
Product Name: HYDROXYCHLOROQUINE SULPHATE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE
CAS Number: 747-36-4
Current Sponsor code: PL17907/0017
Other descriptive name: PLAQUENIL
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 200-600

Primary Outcome(s)

Secondary Objective: Secondary objectives
•Will include assessment of tolerability and treatment-related side effects, partial response, quality of life and cost to the NHS.
Will also include estimation of changes in mucosa-associated bacteria as a result of antibiotic therapy.

Primary end point(s): Remission of Crohn's disease defined as a fall of CDAI to

Main Objective: The Primary Objective
•To compare the efficacy of a combination of antibiotics (Ciprofloxacin and Doxycycline) with standard therapy (oral Budesonide - Entocort CR) in the Treatment of Active Crohn’s Disease.

Secondary Outcome(s)

Secondary ID(s)

3591

Source(s) of Monetary Support

Secondary Sponsor(s)

University of Liverpool

Ethics review

Status: Approved
Approval date: 28/04/2009
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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