A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain

Phase 2 Completed 207 enrolled Alza Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of the study was to characterize the safety, effectiveness, and impact on quality of life (QOL) measures of OROSÂ® hydromorphone HCL in patients with chronic low back pain.

Timeline

Start: —
Primary completion: —
Completion: 2001-11

Publications

Results Wallace M, Skowronski R, Khanna S, Tudor IC, Thipphawong J. Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). Curr Med Res Opin. 2007 May;23(5):981-9. doi: 10.1185/030079907x182040.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Hydromorphone	Other / unclassified	8 mg	Oral
Background	Hydromorphone	Other / unclassified	16 mg	Oral
Background	Hydromorphone	Other / unclassified	32 mg	Oral
Background	Hydromorphone	Other / unclassified	64 mg	Oral
Background	Hydromorphone	Other / unclassified	2 mg	—
Background	Hydromorphone	Other / unclassified	4 mg	—
Background	Hydromorphone	Other / unclassified	8 mg	—

Indications

No indication recorded.