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
Completed
Trial end date:
2001-11-01
2001-11-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alza Corporation, DE, USATreatments:
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.