A Phase 2 interventional study of OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine in Low Back Pain, sponsored by Alza Corporation, DE, USA. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-27.
Sponsored by Alza Corporation, DE, USA (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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.
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 - OROS® hydromorphone HCL conversion, titration, and stabilization phase (3 - 14 days); Phase 3 - OROS® 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 OROS® hydromorphone HCL every 24 hours converted to a once-daily dosing OROS® hydromorphone HCL dose at approximately a 5:1 morphine to hydromorphone equivalent ratio. OROS® hydromorphone HCL dose titration (25-100% baseline dose) was allowed every 2 days to achieve stabilization. OROS® 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. OROS® 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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 207 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Alza Corporation, DE, USA is the lead sponsor of 37 studies on the registry; none are open to participants now.
First submitted after Alza Corporation, DE, USA became part of Johnson & Johnson.
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Exclusion Criteria:
The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;
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.
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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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