Clinical trial NCT00101985 (phase 2, status: completed)
Conditions: irritable colon
ICD codes: K58.2, K58.8, K58.0, K58.1, K58.9
Drugs: talnetant
SMILES: CCC(NC(=O)C1=C(O)C(=NC2=CC=CC=C12)C1=CC=CC=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion criteria:

          -  Subjects will be required to conduct self-assessments of their IBS symptoms using a
             touch-tone telephone system for the duration of the study (15 weeks).

          -  Must be diagnosed with IBS consistent with the Rome II criteria.

          -  Must have normal results from a colonic procedure within 2 years of randomization.

          -  Must have conducted self-assessments on at least 12 days and have a documented average
             IBS pain or discomfort score of greater than or equal to 1.5 during the two-week
             screening phase.

        Exclusion criteria:

          -  Self-assessment of no stool for 7 days during the two-week screening phase.

          -  Clinically significant abnormal laboratory tests.

          -  Current evidence or history of various conditions, comorbidities, or surgeries such as
             Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.

          -  Inability to use the touch-tone telephone system.

          -  Hypersensitivity to quinolone antibiotics or quinolone derivatives.

          -  Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose
             of medication for at least 6 months.

          -  Women who are pregnant, breast feeding, or planning to become pregnant during the
             study.

        Permitted medications: The subject is allowed to take any of the following medications,
        provided they maintain a stable dose for at least 30 days prior to the Screening visit and
        throughout the remainder of the study:

          -  Antidepressants, except REMERON

          -  Antihypercholesterolemics

          -  Iron supplements

          -  Bulking agents

          -  Fiber supplement

          -  Thyroid replacement therapy (levothyroxine)

          -  Antipsychotics

          -  Cox-2 inhibitors (CELEBREX)

        Prohibited medications: Subjects must stop taking any medications they are taking to treat
        their IBS symptoms and must not have taken any of the prohibited medications at least 7
        days prior to the Screening visit and must remain off these medications for the duration of
        the study.

          -  Anticholinergics (dicyclomine, hyoscyamine, propantheline)

          -  Cholinomimetic (bethanechol, pyridostigmine, tacrine, physostigmine)

          -  All narcotics (morphine, codeine, TYLENOL #3, propoxyphene, either alone or in
             combination)

          -  Tramadol hydrochloride (ULTRAM)

          -  Colchicine

          -  Orlistat (XENICAL)

          -  Misoprostol, alone or in combination (ARTHROTEC, CYTOTEC)

          -  5-HT3 receptor antagonists (ondansetron, tropisetron, dolasetron, granisetron,
             mirtazapine, cilansetron, alosetron)

          -  Tegaserod (ZELNORM)

          -  Gabapentin

          -  Lupron

          -  Antacids containing magnesium or aluminium

          -  Antidiarrheal agents

          -  Bismuth compounds

          -  Prokinetic agents (cisapride, metoclopramide)

          -  Sulfasalazine

          -  Laxatives

          -  Cholestyramine