A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment
and 1-week post-treatment follow-up).
Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 [no pain] to 10 [worst possible pain]. Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.
5 weeks (from D-7 (seven days before randomization) up to D28)
Clinical Sciences & Operations
United States: Food and Drug Administration
|Investigational Site Number 840005||Cincinnati, Ohio 45267-0542|
|Investigational Site Number 840006||Flat Rock, North Carolina 28731|