A randomized, double-blind, parallel-group, placebo-controlled study to assess the clinical benefit of SSR411298 as adjunctive treatment for persistent cancer pai

Phase 1

• Conditions: cancer pain; MedDRA version: 14.1Level: LLTClassification code 10069398Term: Breakthrough cancer painSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002557-56-BE
• Lead Sponsor: sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified