Status:
COMPLETED
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ta...
Detailed Description
Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of repeated opioid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have been treated with strong opioids (including hydromorphone and oxycodone) within the last 4 weeks prior to study inclusion or who will probably undergo any treatment (e.g. neurological techniques, surgery) within the next 6 months, which may abruptly alter degree or nature of pain experienced
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00261495
Start Date
March 1 2006
End Date
April 1 2008
Last Update
June 3 2014
Active Locations (52)
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1
Brno, Czechia
2
Pilsen, Czechia
3
Prague, Czechia
4
Copenhagen, Denmark