Clinical trial NCT00101985: Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
Official title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Colon
Keywords: Quality of Life
Irritable bowel syndrome
IBS
SB223412
Qol
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-01-19
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).


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

Primary outcomes:
measure: 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 outcomes:
measure: - 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.
Other outcomes:
Locations:
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country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
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facility: GSK Investigational Site
state: Arizona
city: North Little Rock
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facility: GSK Investigational Site
state: Arkansas
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city: Concord
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facility: GSK Investigational Site
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city: Garden Grove
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city: Boston
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city: Adelaide
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country: France
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country: Germany
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state: Sachsen
city: Dresden
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state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
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city: Stadskanaal
country: Netherlands
facility: GSK Investigational Site
city: Claremont
country: South Africa
facility: GSK Investigational Site
city: N1 City
country: South Africa
facility: GSK Investigational Site
city: Parktown
country: South Africa
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city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Badalona
country: Spain
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city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
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city: Madrid
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Nacka
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Portergate, Sheffield
country: United Kingdom
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: