A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

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).

Timeline

Start

2006-03

Primary completion

2008-04

Completion

2008-04

Outcome

Met primary endpoint

paper The primary efficacy analysis showed that OROS hydromorphone was noninferior to SR oxycodone (P = 0.011) PMID 20384968 ↗

registry analysis (non-inferiority or equivalence test); OROS Hydromorphone HCl vs Oxycodone; p <0.001; Mean Difference (Net) -0.12 (95% CI -0.53 to 0.29) NCT00261495 ↗

Publications

• Results Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydromorphone	Other / unclassified	8 mg	—
Subject	Hydromorphone	Other / unclassified	16 mg	—
Subject	Hydromorphone	Other / unclassified	32 mg	—
Comparator	Oxycodone	Other / unclassified	10 mg	—
Comparator	Oxycodone	Other / unclassified	20 mg	—
Comparator	Oxycodone	Other / unclassified	40 mg	—

Indications

No indication recorded.