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talnetant

Phase 2

Irritable Colon | Small molecule | Other |GSK plc|Last Updated: Apr 13, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment741
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00101985Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)PHASE2 COMPLETED 741 — — Oct 1, 2004Jul 1, 2005Apr 13, 2015135 United States, Australia +9
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Study Endpoints
Primary Endpoints
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 Endpoints
- 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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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
talnetantDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites135

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 with...

Countries:United StatesAustraliaCanadaFranceGermanyNetherlandsSouth AfricaSpainSwedenUnited Kingdom
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