Irritable Colon
Conditions
Keywords
Quality of Life, Irritable bowel syndrome, IBS, SB223412, Qol
Brief summary
This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).
Interventions
DRUGtalnetant
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life. | — |
Countries
Australia, Canada, France, Germany, Netherlands, South Africa, Spain, Sweden, United Kingdom, United States
Outcome results
None listed