Recent Updates
Recently added Catalysts

CG5503

Phase 3

Diabetic Neuropathy | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jul 19, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment395
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00455520A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral NeuropathyPHASE3 COMPLETED 395 — — Apr 1, 2007Aug 1, 2008Jul 19, 2013 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12
Baseline and 12 weeks

For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

Secondary Endpoints
The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.
Start of Open Label and at 12 weeks of Double Blind
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
12 week endpoint
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
12 week endpoint (change from baseline)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORplacebo matching placebo twice daily for 12 weeks
CG5503EXPERIMENTALCG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks
Interventions
NameTypeDescription
CG5503DRUG100, 150, 200, 250 mg twice daily given for up to 15 weeks
placeboDRUGmatching placebo twice daily for 12 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with Type 1 or Type 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening * The investigator considers the patient's blood glucos...

Unlock Eligibility Criteria