efficacy and safety evaluation of transtec for pain therapy such as first line opioid in patients afected by solid tumors with CT treatment . Fase IV study - ND

• Conditions: cancer pain refractary to therapy without opioids; MedDRA version: 9.1Level: HLGTClassification code 10027655Term: Miscellaneous and site unspecified neoplasms malignant and unspecified

• Registration Number: EUCTR2006-001679-39-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

age 18-80 cancer PS 8804; 2 VAS 8805; 60 mm CT therapy
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

- buprenorfin allergy - patients with miastenia gravis or delirium tremens - pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: efficacy of treatment;Secondary Objective: pain free survival;Primary end point(s): pain free survival at six months after therapy with transtec