SEQUENTIAL STUDY ON THE INCIDENCE AND INTENSITY OF INTESTINAL CONSTIPATION ASSOCIATED TO OXYCODONE (OXYCONTIN) AND THE COMBINATION OF OXYCODONE/NALOXONE (TARGIN) FOR CHRONIC ONCOLOGIC PAIN TREATMENT (ONCO_PAIN 01/2009). - ONCO_PAIN01/2009

Conditions: Advanced neoplastic desease with pain
MedDRA version: 9.1Level: LLTClassification code 10045171
MedDRA version: 9.1Level: LLTClassification code 10010774

Registration Number: EUCTR2009-015943-17-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age ≥ 18 years old
Patients in treatment with oxycodone CR with a maximum dose of 40 mg/die
Patients with controlled pain, corresponding to a NRS value <3 for 7 consecutive days at least
Patients which is expected to follow at site for at least one month of treatment
Signed Informed Consent obtained
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

Patients in treatment with other opioids than Oxycodone
Patients with positive medical history for hypersensitivity reaction at Oxycondone
Patients with renal failure (creatinine > 2mg/dl)
Patients with hepatic failure (bilirubine > 2 mg/dl)
Patients not able to swallow oral medications
Pregnancy or breastfeeding
Patients in treatment for psychosis
Patients in treatment with vincas derived (vinblastine or vincristine)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to evaluate incidence and intensity of constipation in patients in treatment with oxycodone who switch to oxycodone/naloxone combination. This will be evaluated in terms of constipation reduction, assessed with a daily questionnaire;Secondary Objective: Will also be evaluated the analgesic effect of the combination.;Primary end point(s): The evaluation of constipation will be performed on the basis of a daily questionnaire completed by the patient.

Secondary Outcome Measures