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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00101985




Registration number
NCT00101985
Ethics application status
Date submitted
18/01/2005
Date registered
19/01/2005
Date last updated
13/04/2015

Titles & IDs
Public title
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
Scientific 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
Secondary ID [1] 0 0
223412/068
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Colon 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - talnetant

Treatment: Drugs: talnetant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
- 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.
Timepoint [1] 0 0

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2005
Sample size
Target
Accrual to date
Final
741
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
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GSK Investigational Site - Concord
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GSK Investigational Site - Newtown
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GSK Investigational Site - Kippa Ring
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GSK Investigational Site - Spring Hill
Recruitment hospital [6] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [8] 0 0
GSK Investigational Site - Port Lincoln
Recruitment hospital [9] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [10] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [11] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [12] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2042 - Newtown
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4000 - Spring Hill
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment outside Australia
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Portergate, Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the effectiveness and safety of the investigational drug talnetant
in treating subjects with irritable bowel syndrome (IBS).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00101985
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00101985