Crohn's Disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Ciprofloxacin
Product Code: PL 20532/0012
Pharmaceutical Form: Tablet
INN or Proposed INN: Ciprofloxacin hydrochloride
CAS
Sponsors
Royal Liverpool & Broadgreen University Hospitals Trust
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 </= 150 at 10 weeks. | — |
Countries
United Kingdom
Outcome results
None listed