Overview

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

Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study was to characterize the safety, effectiveness, and impact on quality of life (QOL) measures of OROS® hydromorphone HCL in patients with chronic low back pain.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alza Corporation, DE, USA
Treatments:
Hydromorphone
Criteria
Inclusion Criteria:

- Patient with chronic low back pain who were currently receiving strong oral or
transdermal opioid analgesics on a daily basis, or patients suitable for advancement
of therapy to step 3 of the World Health Organization (WHO) analgesic ladder were
considered for enrollment in the study. Patients requiring >8 and =96 mg of OROS®
hydromorphone HCL every 24 hours were enrolled in the study.

Exclusion Criteria:

- Patients intolerant or hypersensitive to hydromorphone or other opioid agonists and
patients with a known history of alcohol or drug abuse within the previous year were
excluded from study.