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4L PegLyte + bisacodyl

Phase 3

Colonoscopy | Small molecule | Gastrointestinal |Edesa Biotech, Inc.|Last Updated: Feb 21, 2020

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment196
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02976805Multi-centre Failed Bowel Prep RCTPHASE3 COMPLETED 196 — — Feb 13, 2017Feb 19, 2020Feb 21, 20204 Canada
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Study Endpoints
Primary Endpoints
Adequate bowel preparation
Once after colonoscopy

BBPS total score ≥6 and/or all segment scores ≥2.

Secondary Endpoints
Mean BBPS total score
Once after colonoscopy
Bowel preparation was adequate after washing to visualize lesions > 5 mm of importance to the procedure and there is no need to shorten the interval of the next colonoscopy
Once after colonoscopy
Validated patient tolerability questionnaire for bowel preparation score
Once after colonoscopy
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Regimen AEXPERIMENTAL4L PegLyte + 15 mg bisacodyl
Regimen BEXPERIMENTAL6L PegLyte + 15 mg bisacodyl
Interventions
NameTypeDescription
4L PegLyte + 15 mg bisacodylDRUGRandomized
6L PegLyte + 15 mg bisacodylDRUGRandomized
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Anyone undergoing a repeat colonoscopy due to failed bowel preparation at index colonoscopy. Failure is defined as preparation quality inadequate to detect lesions \> 5 mm after washing and requiring a shortened colonoscopy interval as a result. 2. Age \> 18 years 3. Outpatie...

Countries:Canada
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