Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00101985
First received: January 18, 2005
Last updated: October 10, 2013
Last verified: April 2013

January 18, 2005
October 10, 2013
October 2004
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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.
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Complete list of historical versions of study NCT00101985 on ClinicalTrials.gov Archive Site
- 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.
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Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Colon
Drug: talnetant
Other Name: talnetant
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
670
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Netherlands,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00101985
223412/068
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP