CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 504 enrolled
Drug / intervention
OROS hydromorphone HCl +1 moredrug
Likely dose
OROS hydromorphone HCl 32 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00261495
NCT00261495Phase 3Completed
CompareCT.gov

Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.

Janssen Pharmaceutica N.V., Belgium·interventional·Posted Dec 5, 2005·Updated Jun 3, 2014

In Brief

A Phase 3 clinical trial evaluating OROS hydromorphone HCl and Oxycodone for Pain. Completed, enrolled 504 participants across 52 sites in 10 countries.

Detailed Summary

The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesCzechia, Denmark, France, Germany, Norway, Poland, Slovakia, Slovenia, Sweden, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2005
Enrollment StartMar 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.6 years ago

Interventions

OROS hydromorphone HCldrug

8 to 32 mg once daily for 52 weeks (flexible dosing)

Oxycodonedrug

10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)