Clinical trial NCT00509639 (phase 3, status: completed)
Conditions: crohn's disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: 10% metronidazole ointment
SMILES: [H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O
Eligibility criteria:

        Inclusion Criteria:

          -  Have Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal
             involvement.

          -  Have had perianal symptoms for longer than 3 months

          -  Have a PCDAI of 5 or above at baseline

          -  Subjects can be on concomitant medication. Acceptable regimes are:-

          -  Aminosalicylates at a dosage that has been stable for more than 4 weeks before
             screening;

          -  Oral corticosteroids <40mg per day that has been stable for more than 3 weeks;

          -  Methotrexate given for at least 3 months that has been stable for more than 4 weeks;
             Azathioprine or mercaptopurine given for at least 6 months at dosage that has been
             stable for more than 8 weeks;

          -  Antibiotics at a dosage that has been stable for 4 weeks (subjects may be on oral
             metronidazole but on a dose not more than 750mg per day),

          -  Cycolsporin for more than 3 months and on a stable dose for more than 4 weeks;

          -  Patients who have been treated with Infliximab must have received their initial dose 3
             months before starting study medication and their most recent dose at least 8 weeks
             before starting study medication and not receive an infusion whilst in the
             double-blind treatment phase of the study for 4 weeks. During the second 4 week open
             stage of the study patients can commence again a maintenance regime with Infliximab
             treatment if deemed necessary

          -  Any patients not on concurrent medication must have been off medication for at least 4
             weeks before screening.

          -  If patients have Setons these must have been in place for at least 4 weeks prior to
             screening.

          -  Subjects must be aged 18 years or over and of the legal age of consent.

          -  If female, the subject must not be lactating and must be (a) post- menopausal, (b)
             surgically sterilised, or (c) have a negative pregnancy test result prior to entry
             into the study and will use double- barrier methods of contraception (two separate
             methods of birthcontrol one of which may include oral contraception) for the duration
             of the study.

          -  Must have provided written informed consent to participate.

        Exclusion Criteria:

          -  They have had surgery to the anus or rectum in the past 4 weeks;

          -  They have a perianal abscess requiring incision and drainage;

          -  They have a stoma of less than 6 months duration;

          -  Allergic to metronidazole;

          -  Are taking any prohibited medication.

          -  Deemed mentally incompetent.

          -  Considered by their physician unlikely to be able to comply with the protocol.

          -  Taken part in an experimental drug study in the preceding three months.