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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01783106
Date of registration: 31/01/2013
Prospective Registration: Yes
Primary sponsor: Royal Liverpool University Hospital
Public title: Antibiotics and Hydroxychloroquine in Crohn's APRiCCOT
Scientific title: A Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease
Date of first enrolment: February 1, 2014
Target sample size: 59
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01783106
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient is willing to participate in the study and has signed the informed consent

- Patients aged 18 or over with Crohn's disease diagnosed by conventional clinical,
radiological and histological criteria.

- Crohn's disease involving small bowel, colon or both.

- Active Crohn's disease: Crohn's Disease Activity Index (CDAI)> 220 and CRP>10mg/l.

- Patients receiving mesalazine (5ASA) must have had a stable dose for at least one
month.

- Patients receiving Azathioprine, or Mercaptopurine (who will be separately stratified)
must have had a stable dose for at least 3 months

- Women of child bearing potential must have a negative urine pregnancy test prior to
the start of study medication

Exclusion Criteria:

- Patients under 18 or unable to give informed consent.

- Any antibiotic use within the previous 4 weeks

- Known sensitivity to Ciprofloxacin, Doxycycline, Hydroxychloroquine, or Budesonide

- Patients with a history of tendon disorders related to Fluoroquinoline administration

- Any change to immunosuppressive therapy (Azathioprine, or Mercaptopurine) within the
previous 3 months.

- Use of Infliximab or Adalimumab (anti-TNF antibody) or methotrexate within the
previous 3 months

- Concurrent use of systemic corticosteroids in excess of oral prednisolone 5 mgs/day or
budesonide 3mg/day)

- Any change to medication for Crohn's disease in previous 4 weeks.

- 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)

- Pregnant, post-partum (<3months) or breast feeding females

- Patients with abnormal visual acuity (that does not correct with glasses) or
unexplained visual symptoms

- 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.

- 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, or Cyclosporine



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Budesonide
Drug: Ciprofloxacin
Drug: Doxycycline
Drug: Hydroxychloroquine
Primary Outcome(s)
• Remission, defined as CDAI =150 maintained through to 24 weeks [Time Frame: 24 weeks]
• Remission, defined as CDAI =150 maintained through to 52 weeks [Time Frame: 52 weeks]
• Remission, defined as Crohn's Disease activity index (CDAI) <150 at 10 weeks without addition of any other medication or treatment for the Crohn's Disease. [Time Frame: 10 weeks]
Secondary Outcome(s)
• Adverse Events and possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at each visit [Time Frame: throughout 12 month follow-up]
• Fall in Faecal Calprotectin [Time Frame: 4 weeks, 10 weeks, 24 weeks, 52 weeks]
• Markers of cost (days admitted to hospital, days unable to carry out normal daily activities, need for surgery) [Time Frame: 52 weeks]
• Patient global assessment of symptom severity by 10 cm visual analogue score at 4 weeks, at 10 weeks, or Early Withdrawal [Time Frame: 4 weeks and 10 weeks]
• Quality of life at 4 weeks, at 10 weeks, or Early Withdrawal [Time Frame: 4 weeks and 10 weeks]
• Remission defined as CDAI <150 at 4 weeks [Time Frame: 4 weeks]
• Response defined as a fall in CDAI by >70 points at 4 weeks and 10 weeks [Time Frame: 4 weeks and 10 weeks]
Secondary ID(s)
2008-001137-99
Royal_Liverpool
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Association for Colitis and Crohn's Disease
National Institute for Health Research, United Kingdom
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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