Status:
COMPLETED
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
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study was a short-term, non-randomized (each patient was assigned the same treatment from phase I through phase III by the researchers), non-comparative, open-label, repeated dose study of OROS® ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2001
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00398788
End Date
November 1 2001
Last Update
April 27 2010
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