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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015943-17-IT
Enrollment
30
Registered
2009-11-17
Start date
2010-04-23
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced neoplastic desease with pain MedDRA version: 9.1 Level: LLT Classification code 10045171 MedDRA version: 9.1 Level: LLT Classification code 10010774

Interventions

Trade Name: OXYCONTIN Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Oxycodone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name:

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026