NCT01439919

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Breakthrough Cancer Pain

Interventions

Type	Name	Description
DRUG	SSR411298	Form: tablet Route: oral administration with food
DRUG	Placebo (for SSR411298)	Form: tablet Route: oral administration with food

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-09-23
• Last updated: 2013-03-21

Locations

2 sites across 1 country: United States