Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)

Phase 3 Completed 388 enrolled Alza Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain.

Timeline

Start: —
Primary completion: —
Completion: 2000-06

Publications

Wallace M, Moulin DE, Rauck RL, Khanna S, Tudor IC, Skowronski R, Thipphawong J. Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain. J Opioid Manag. 2009 Mar-Apr;5(2):97-105. doi: 10.5055/jom.2009.0011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydromorphone	Other / unclassified	8 mg	Oral
Subject	Hydromorphone	Other / unclassified	16 mg	Oral
Subject	Hydromorphone	Other / unclassified	32 mg	Oral
Subject	Hydromorphone	Other / unclassified	64 mg	Oral

Indications

No indication recorded.