cancer pain MedDRA version: 14.1 Level: LLT Classification code 10069398 Term: Breakthrough cancer pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Code: SSR411298
Pharmaceutical Form: Tablet
INN or Proposed INN: SSR411298
CAS Number: 666860-59-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Phar
Sponsors
sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with moderate or severe, persistent cancer pain who are receiving World Health Organization (WHO) Step 2 or 3 cancer pain treatment (2) as Background Therapy (BT) - Pain generator must be primarily due to underlying cancer or cancer treatment - Pain generator must be classified as either primarily nociceptive or primarily neuropathic - Pain severity must be moderate or severe, as defined as an NRS score of =4 during the SP (note: average NRS score = average pain intensity (not highest or lowest pain intensity) for each day of the SP, averaged over the SP) - World Health Organization Step 2 or 3 cancer pain treatment as BT consists of opioids ± non-opioids ± adjuvants ± rescue therapy for breakthrough pain + For patients with primarily nociceptive cancer pain (NCCP), examples of permitted adjuvant pain treatments are corticosteroids, bisphosphonates, etc, with planned administration to be stable during the study + For patients with primarily neuropathic cancer pain (NPCP), examples of permitted adjuvant pain treatments are antidepressants or antiepileptics, etc, with planned administration to be stable during the study - Dose adjustment of BT is permitted during the study but any change other than dose adjustment of BT is prohibited • Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Instability of pain between Visit 1 (Day 7) and Visit 2 (Day 1) • “Satisfied” or “extremely satisfied” response on the 5-point Likert patient satisfaction of pain relief scale at Visit 1 (Day -7) or Visit 2 (Day -1) • Prohibited adjuvant pain treatments in the week prior to Visit 1 (Day 7) or planned administration during the study - For patients with primarily NCCP, the prohibited adjuvant pain treatments are antidepressants or antiepileptics - For patients with primarily NPCP, antidepressants or antiepileptics are permitted but the simultaneous use of both an antidepressant and antiepileptic is prohibited • Use of tetradydrocannabinol (THC) compounds for the treatment of pain • Chemotherapy within 4 weeks of Visit 1 (Day -7) or chemotherapy planned during the study (a stable regimen of hormonal therapy is permitted) • Radiotherapy within 4 weeks of Visit 1 (Day 7) or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted) • Cancer-related surgery within 4 weeks of Visit 1 (Day 7) or cancer-related surgery planned during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain, as measured by the change from baseline (baseline = average pain intensity between Visit 1 (Day 7) and Visit 2 (Day 1) to end of treatment (end of treatment = average pain intensity during Week 4) in the Numeric Rating Scale (NRS);Secondary Objective: • To evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain, as measured by a variety of secondary efficacy endpoints • 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 ;Primary end point(s): • Change from baseline (baseline = average pain intensity between Visit 1 (Day 7) and Visit 2 (Day 1) to end of treatment (end of treatment = average pain intensity during Week 4) in the NRS - NRS is a daily assessment performed at the same time each day at the end of the day ;Timepoint(s) of evaluation of this end point: D-7, D-1 and D28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy • Brief Pain Inventory Short-Form (BPISF) (3,4) • Responder rate: reduction of =30% of pain intensity; reduction of =50% of pain intensity; pain composite (pain intensity or BT utilization) • Breakthrough pain frequency • Background Therapy utilization: morphine-equivalent dose per day; adjuvant agent utilization; number of rescue medication doses per day • Mood disorders: Hospital Anxiety and Depression Scale (HADS) (5) • Nausea visual analog scale (VAS) • Constipation: Bowel Function Index (BFI) score (6); amount of laxative medication use recorded at each assessment visit • Health care utilization: unscheduled hospitalizations, emergency department visits, healthcare provider office visits and sick leave days • Patient satisfaction of pain relief: 5point Likert scale • Quality of life: European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireC30 (EORTC QLQC30) version 3 (7) Safety • Adverse events (AEs) and other clinical and para-clinical parameters (eg, vital signs, physical examination, clinical laboratories, electrocardiography) • Suicidality assessment (Columbia Suicide Severity Rating Scale [CSSRS]) (8) • Drug Abuse and Liability Assessment (DALA) (9) • Cognitive function tests: Digit-Symbol Substitution Test (DSST) (10), Rey Auditory Verbal Learning Test (RAVLT) (11), and 2Digit Cancellation Test (2-DCT) (12) • Pill dysphagia assessment Other • SSR411298 plasma concentrations • Endocannabinoid plasma concentrations • SAR250960 urine concentration ;Timepoint(s) of evaluation of this end point: From D-7 to D35 | — |
Countries
Belgium, Czech Republic, France, Hungary, Italy, Netherlands, Russian Federation, United States
Contacts
Public ContactJean Van Rampelbergh
sanofi-aventis Belgium
Outcome results
None listed