CANCER PAI

• Conditions: cancer pain; MedDRA version: 14.1Level: PTClassification code 10027484Term: Metastatic painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-002557-56-IT
• Lead Sponsor: SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-23
• Last Update Posted: 1 May 2012

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 - 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 • Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 • 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