- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398788
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
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 Overview
Status
Conditions
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® 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
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Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
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University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
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Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
Clinical Trials on OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine
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Alza Corporation, DE, USACompleted