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
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain
Intervention: OROSĀ® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine (Drug)
Phase: Phase 2
Sponsored by: Alza Corporation, DE, USA
Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: ALZA
The purpose of the study was to characterize the safety, effectiveness, and impact on
quality of life (QOL) measures of OROSĀ® hydromorphone HCL in patients with chronic low back
Official title: An Open-Label, Repeated-Dose Trial to Characterize the Efficacy and Safety, and Impact on Quality of Life Measures of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;
Secondary outcome: The overall global evaluation and Brief Pain Inventory (BPI) of study drug, as assessed by both patients and Investigators at weekly visits during the 4 week maintenance phase.
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® hydromorphone HCL consisting of 3 phases: Phase 1 - prior opioid
stabilization phase (2-7 days); Phase 2 - OROSĀ® hydromorphone HCL conversion, titration, and
stabilization phase (3 - 14 days); Phase 3 - OROSĀ® hydromorphone HCL maintenance therapy
phase (28 days) Before Phase 1, patients must have had no change in their prescribed opioid
regimen over the prior 30 days. During Phase 1, patients were to have demonstrated 2
consecutive days of stable baseline oral or transdermal opioid medication.
During Phase 2, patients requiring =96 mg OROSĀ® hydromorphone HCL every 24 hours converted
to a once-daily dosing OROSĀ® hydromorphone HCL dose at approximately a 5: 1 morphine to
hydromorphone equivalent ratio. OROSĀ® hydromorphone HCL dose titration (25-100% baseline
dose) was allowed every 2 days to achieve stabilization. OROSĀ® hydromorphone HCL dose
reduction was allowed during Phases 2 and 3 for opioid-related adverse events (AEs). Rescue
medication, Dilaudid IR (immediate release) was allowed during all 3 phases. During Phase 3,
patients attended 4 weekly study visits to provide diary information about study medication
and rescue medication usage, daily pain relief scores and adverse events, and to receive
weekly supplies of study medications. OROSĀ® hydromorphone HCL tablets of 8,16, 32, or 64
mg depending on Phase I stable baseline oral or transdermal opioid medication, 2-7 days;
study drug dose titration was allowed every 2 days to achieve stabilization in Phase II,
3-14 days; Phase III , maintenance therapy phase 28 days; study drug dose reduction was
allowed during Phase 2 and 3 for opioid-related adverse events. Rescue medication of
Dilaudid IR (immediate release) 2, 4, 8mg tablets were allowed during all phase.
Minimum age: 18 Years.
Maximum age: N/A.
- 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 OROSĀ®
hydromorphone HCL every 24 hours were enrolled in the study.
- 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.
Locations and Contacts
Last updated: April 26, 2010