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

Inclusion Criteria

Inclusion criteria:

Patient with moderate or severe, persistent cancer pain who is receiving the World Health
Organization (WHO) Step 2 or 3 cancer pain treatment:

- Pain generator (source of pain) must be primarily due to underlying cancer or cancer
treatment;

- Pain generator (source of pain) must be classified as either primarily nociceptive or
primarily neuropathic;

- Pain severity must be moderate or severe with an average NRS score ≥4 during the
screening week.

Exclusion criteria:

- Instability of pain during the screening week;

- Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to
use these medications during the study;

- Current use of medication containing tetrahydrocannabinol (THC);

- Chemotherapy within 4 weeks before study entry or chemotherapy planned during the
study (a stable regiment of hormonal therapy is permitted);

- Radiotherapy within 4 weeks before study entry or radiotherapy planned during the
study (hemostatic palliative radiotherapy is permitted);

- Cancer related surgery within 4 weeks before study entry or cancer-related surgery
planned during the study.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.