Randomized phase II trial evaluating the activity and the tolerability of fixed dose of oxycodone and increasing dose of pregabalin versus increasing dose of oxycodone and fixed dose of pregabalin - ND

• Conditions: patients affected with cancer and presenting a neuropatic component in their pain; MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders

• Registration Number: EUCTR2007-005222-69-IT
• Lead Sponsor: Associazione Progetto Oncologia UMAN.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-written informed consent -instrumental and clinical diagnosis of every malignant neoplasm -presence of pain with a neuropatic component in the opinion of the physician -presence of pain >=4 (NRS) -PS ECOG <3
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-serum creatinine >2mg/ml or creatinine clearance <40 ml/min -mild or severe hepatic insufficiency -iatrogenic neuropathy caused by chemotherapeutic agents -previous allergic reactions to oxycodone and pregabalin -pregnancy or breastfeeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Achievement of analgesia (decrease of at least 1/3 of pain intensity);Secondary Objective: -Pain control rate -Reduction of Break Through Pain number -Record of adverse events -Reduction of allodynia in patients presenting it at T0 -Patient satisfaction -Number of needing of rescue doses -Ancillary study on patient's blood (pharmacokinetics, pharmacodynamics,genetic polymorphisms);Primary end point(s): Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale