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Long term opioid administration in no-oncologic chronic pain: open label, prospective study on efficacy, safety and pharmacokinetic factors - ND

Long term opioid administration in no-oncologic chronic pain: open label, prospective study on efficacy, safety and pharmacokinetic factors - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002292-27-IT
Enrollment
Unknown
Registered
2008-05-21
Start date
2008-06-23
Completion date
Unknown
Last updated
2014-06-30

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

Conditions

chronic pain MedDRA version: 9.1 Level: LLT Classification code 10049475 Term: Chronic pain

Interventions

Trade Name: ORAMORPH*OS SOL FL 120ML 20MG/ Pharmaceutical Form: Oral solution INN or Proposed INN: Morphine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration nu

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age > 18 years, chronic, neurophatic and/or nocicettive periferic pain 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

Exclusion criteria: oncologic patients, patients with abuse history, with history of opioid analgesic use, with known sensibility to opioid, ...

Design outcomes

Primary

MeasureTime frame
Main Objective: -to identify opioid product with the best clinical-pharmacological efficacy-safety profile -to identify genetic polymorphism related to the best clinical response;Secondary Objective: to evaluate opioid pharmacokinetic;Primary end point(s): pain reduction at least 40% in VAS scale—

Countries

Italy

Outcome results

None listed

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