Clinical trial NCT00609973 (phase 2, status: completed)
Conditions: crohn's disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: ciprofloxacin, placebo
SMILES: OC(=O)C1=CN(C2CC2)C2=CC(N3CCNCC3)=C(F)C=C2C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Man or woman between 18 and 70 years of age.

          -  Diagnosis of Crohn's disease confirmed during index surgery.

          -  Detailed assessment of disease localization by colonoscopy, small bowel radiography,
             and/or other appropriate methods (e.g., MRI, CT) within 6 months prior inclusion into
             the study.

          -  Resection for ileal or ileo-colonic Crohn's disease with ileo-colonic anastomosis
             (i.e., without grossly visible disease at the resection margins); neoterminal ileum
             should be assessable by endoscopy.

          -  Ability to start oral nutrition and medication intake within 14 days after index
             surgery.

          -  Negative pregnancy test at screening visit in females of childbearing potential.

          -  Use of appropriate contraceptive methods for females of childbearing potential and
             males with procreative capacity during treatment.

        Exclusion Criteria:

          -  Short bowel syndrome.

          -  Previous long term therapy with ciprofloxacin (> 6 weeks prior before surgery)

          -  Patients in whom any visible lesions at the anastomosis were left after index surgery.

          -  Serious secondary illnesses of an acute or chronic nature, which in the opinion of the
             Investigator renders the patient unsuitable for inclusion into the study.

          -  Dementia

          -  Uncontrolled Diabetes Type I type II

          -  Known drug abuse

          -  Known parasitic disease of the digestive system

          -  Active replicating Hepatitis B or Hepatitis C

          -  HIV-infection

          -  Seizure disorder

          -  Serum creatinine levels exceeding 1.5 mg/dL or 130 μmol/L.

          -  Presence of an ileal or colonic stoma.

          -  Known previous or concurrent malignancy (other than that considered surgically cured,
             with no evidence for recurrence for 5 years).

          -  Application of non-steroidal anti-inflammatory drugs as long term treatment.

          -  Known intolerance/hypersensitivity to ciprofloxacin or other quinolones or drugs of
             similar chemical structure or pharmacological profile.

          -  Chronic use of CYP1A2 substrates (aminophylline, fluvoxamine, mexiletine, mirtazapine,
             ropinirole, tizanidine, trifluoperazine)

          -  Well-founded doubt about the patient's cooperation.

          -  Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 3
             months.

          -  Non-use of appropriate contraceptives in females of childbearing potential (e.g.
             condoms, intrauterine device [IUD], hormonal contraception for females, or a means of
             contraception for a particular patient considered adequate by the responsible
             investigator) during treatment.

          -  Participation in another clinical trial within the last 30 days, simultaneous
             participation in another clinical trial, or previous participation in this trial.