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Randomized, open label, comparative parallel group study to assess efficacy and safety of flexible dosages of OROS hydromorphone once-daily compared to sustained release oxycodone twice-daily in subjects with chronic non-malignant pain severe enough to require continuous opioid therapy.

Randomized, open label, comparative parallel group study to assess efficacy and safety of flexible dosages of OROS hydromorphone once-daily compared to sustained release oxycodone twice-daily in subjects with chronic non-malignant pain severe enough to require continuous opioid therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-005187-24-IT
Enrollment
Unknown
Registered
2005-08-24
Start date
2005-08-16
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Treatment of chronic non-malignant pain MedDRA version: 6.1 Level: PT Classification code 10033371

Interventions

Product Name: OROS hydromorphone Product Code: 71-68-1 Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Hydromorphone Concentration unit: mg milligram(s) Concentration type: equal Co

Sponsors

JANSSEN-CILAG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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:

Design outcomes

Primary

MeasureTime frame
Primary end point(s): ;Main Objective: ;Secondary Objective:—

Countries

Czech Republic, Germany, Italy

Outcome results

None listed

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