Clinical trial NCT01439919: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Breakthrough Cancer Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
Secondary outcomes:
measure: Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Responder rates
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Breakthrough pain frequency
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Opioid consumption expressed as the morphine-equivalent dose per day
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Rescue medication consumption expressed as the number of rescue medication doses per day
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Mood disorders as measured by the Hospital, Anxiety & Depression Scale (HADS)
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Change in nausea as measured by Visual Analog Scale (VAS)
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Constipation as measured by the Bowel Function Index (BFI)
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Healthcare utilization
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Patient satisfaction of pain relief
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) version 3
timeFrame: 5 weeks (from D-7 (seven days before randomization) up to D28)
measure: Overview of adverse events (AE)
timeFrame: up to 5 weeks (from 1st study drug intake up to 7 days after last study drug intake)
measure: SSR411298 plasma concentration
timeFrame: predose and 3-5 hours after study drug intake on Day D14 and Day 28
Other outcomes:
Locations:
city: Flat Rock
country: United States
facility: Investigational Site Number 840006
state: North Carolina
city: Canton
country: United States
facility: Investigational Site Number 840005
state: Ohio
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: