A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.
3 other identifiers
interventional
504
9 countries
48
Brief Summary
The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Mar 2006
Typical duration for phase_3 pain
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
December 24, 2012
CompletedJune 3, 2014
May 1, 2014
2.1 years
December 2, 2005
November 20, 2012
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)
Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
baseline and week 24
Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)
Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
baseline and week 24
Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
week 24
Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)
If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
week 24
Equi-analgesic Dose at Steady-state (PP Population)
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
week 4 to week 24
Equi-analgesic Dose at Steady State (ITT Population)
Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
week 4 to week 24
Secondary Outcomes (73)
Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)
baseline and week 24
Change From Baseline in Sleep Quality at Week 24
baseline and week 24
Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24
baseline and week 24
Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24
baseline and week 24
Number of Subjects With Dose Escalation
week 4 and week 24
- +68 more secondary outcomes
Study Arms (2)
Oxycodone
ACTIVE COMPARATOROROS hydromorphone HCl
EXPERIMENTALInterventions
8 to 32 mg once daily for 52 weeks (flexible dosing)
Eligibility Criteria
You may qualify if:
- Adult patients with chronic noncancer pain severe enough to require continuous opioid therapy (a score of at least 5 in "pain right now" on a 11 point numeric rating scale) who have never received an opioid or are currently treated with a weak opioid, and who experience insufficient pain control.
You may not qualify if:
- patients with a history of disease(s), current illness, or therapy which would preclude them from participation in the study
- and patients who are pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Unknown Facility
Brno, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Copenhagen, Denmark
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Esbjerg, Denmark
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Nyborg, Denmark
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Svendborg, Denmark
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Vejle, Denmark
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Amiens, France
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Bois-Guillaume, France
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Lille, France
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Paris, France
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Berlin, Germany
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Drensteinfurt, Germany
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Dresden, Germany
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Duderstadt, Germany
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Frankfurt, Germany
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Giessen, Germany
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Göppingen, Germany
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Hamburg, Germany
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Herne, Germany
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Jena, Germany
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Kiel, Germany
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Kÿln, Germany
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Ludwigshafen, Germany
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Mannheim, Germany
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Nuremberg, Germany
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Regensburg, Germany
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Rodgau, Germany
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Wiesbaden, Germany
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Bodø, Norway
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Lørenskog, Norway
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Oslo, Norway
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Gdansk, Poland
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Krakow, Poland
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Lublin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Martin, Slovakia
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Prešov, Slovakia
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Ljubljana, Slovenia
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Maribor, Slovenia
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Slovenj Gradec, Slovenia
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Gothenburg, Sweden
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Jönköping, Sweden
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Kristianstad, Sweden
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Linköping, Sweden
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Aarau, Switzerland
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Basel, Switzerland
Unknown Facility
Lausanne, Switzerland
Related Publications (1)
Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.
PMID: 20384968RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMEA Medical Affairs Director Analgesia
- Organization
- Janssen Pharmaceutica NV
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 5, 2005
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
June 3, 2014
Results First Posted
December 24, 2012
Record last verified: 2014-05