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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
  Purpose

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


Condition Intervention Phase
Irritable Colon
Drug: talnetant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • - 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.

Estimated Enrollment: 670
Study Start Date: October 2004
Intervention Details:
    Drug: talnetant
    Other Name: talnetant
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101985

  Show 135 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00101985     History of Changes
Other Study ID Numbers: 223412/068
Study First Received: January 18, 2005
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Quality of Life
Irritable bowel syndrome
IBS
SB223412
Qol

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014