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
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Pain
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00398788
First Posted
November 10, 2006
Last Updated
April 26, 2010
Sponsor
Alza Corporation, DE, USA
1. Study Identification
Unique Protocol Identification Number
NCT00398788
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alza Corporation, DE, USA
4. Oversight
5. Study Description
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® 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine
Primary Outcome Measure Information:
Title
The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alza Corporation Clinical Trial
Organizational Affiliation
ALZA
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17519065
Citation
Wallace M, Skowronski R, Khanna S, Tudor IC, Thipphawong J. Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). Curr Med Res Opin. 2007 May;23(5):981-9. doi: 10.1185/030079907x182040.
Results Reference
result
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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
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