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

Phase 2TerminatedNCT01439919

Sanofi5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain Breakthrough Cancer Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.