This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.
This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.
Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.
Change in worst pain as assessed using the Numeric Pain Rating Scale (NPRS)
Change from baseline to Week 4 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)
Time frame: Baseline to Week 4
Change in worst pain as assessed using the NPRS
Change from baseline to Weeks 8 and 12 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)
Time frame: Baseline to Weeks 8 and 12
Change in area under the curve (AUC) of worst pain as assessed using the NPRS
AUC calculated on change from baseline through Week 4 in worst pain in the target pain location over the previous 24 hours, using the NPRS (0-10)
Time frame: Baseline through Week 4
Incidence and severity of adverse events (AEs)
Incidence and severity of AEs assessed using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time frame: Baseline through Week 12
Change in Quality of Life (QOL) as assessed using the modified Brief Pain Inventory-Short Form (BPI-SF)
Change in Quality of Life from baseline to week 4 based on total score from the BPI-SF, modified to record the target pain treated with study drug
Time frame: Baseline to Week 4
Duration of response in subjects who experienced ≥20% decrease from baseline in worst pain as assessed using the NPRS
Duration of response defined as time from ≥20% decrease from baseline in worst pain score in the target pain location to ≥20% increase from the nadir of the worst pain score
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Time frame: Randomization through Week 12
Change in intensity of average pain as assessed using the NPRS
Change from baseline to Week 4 in the intensity of average pain over the previous 24 hours in the target pain location as measured by the NPRS (0-10)
Time frame: Baseline to Week 4