CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
Hydromorphone HCl +2 moredrug
Likely dose
Hydromorphone HCl 32 milligramfrom 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/NCT01205126
NCT01205126Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Sep 20, 2010·Updated Feb 3, 2014

In Brief

A Phase 3 clinical trial evaluating Hydromorphone HCl, Oxycodone HCl CR, and 1 other intervention for Pain. Completed, enrolled 260 participants across 12 sites.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2010
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago

Interventions

Hydromorphone HCldrug

Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

Oxycodone HCl CRdrug

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

Placebodrug

Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.