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GW876008

Phase 2

Irritable Bowel Syndrome (IBS) | Small molecule | Gastrointestinal |GSK plc|Last Updated: Jan 31, 2018

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment133
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421707Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel SyndromePHASE2 COMPLETED 133Oct 14, 2006Jun 25, 2008Jan 31, 201823 United States, Canada
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Study Endpoints
Primary Endpoints
Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).
Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)

For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).
Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).

For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2
Up to Day 105

For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.

Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen
Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.

Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale
Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.

Secondary Endpoints
Number of Participants With Improvements in Pain and Discomfort
Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Change From Baseline in Pain Severity Scores
Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Percentages of Pain-free Days
Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GW876008EXPERIMENTALGW876008
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
GW876008DRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol * The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within ...

Countries:United StatesCanada
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