Spots Global Cancer Trial Database for A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain

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Trial Identification

Brief Title: A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain

Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain

Study ID: NCT01439919

Conditions

Pain

Breakthrough Cancer Pain

Interventions

SSR411298

Placebo (for SSR411298)

Study Description

Brief Summary: The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Secondary Objectives are: * To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life; * To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain; * To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment; * To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain; * To assess endocannabinoid plasma concentrations.

Detailed Description: 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 therapy.