A Study of the Effectiveness and Safety of Sustained-Release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Information source: Janssen Pharmaceutica N.V., Belgium
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: hydromorphone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Janssen Pharmaceutica N.V., Belgium
Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V., Belgium
The purpose of this study is to compare the effectiveness and safety of sustained- release
hydromorphene, 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 hydromorophene that provides a level of
pain control that is equal to the pain control provided by control-released oxycodone
Official title: Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROSŪ Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-Malignant Pain Requiring Continuous Opioid Therapy.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by oxycodone (equi-analgesic dosage).
Secondary outcome: Patient assessment of pain severity on a 10 point scale; the use of add-on medication (for excessive pain); Brief Pain Inventory (a questionnaire for the patient to acess the severity of their pain and jmpact experienced); and other questionnaires.
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 intake, sustained-release formulations of oxycodone and hydromorphone were
developed that allow twice-daily dosing. Subsequently, a novel, once-daily, extended-release
hydromorphone formulation was developed to further enhance ease of treatment and improve
effectiveness in the treatment of severe pain. This is a randomized, open-label, comparative,
parallel-group, 24-week flexible-dose study in patients with chronic noncancer pain severe
enough to require continuous opioid therapy. Patients will receive either 8 mg of
sustained-release hydromorphene, taken once daily or 10 mg of controlled-release oxycodone,
taken twice daily. Individual adjustments in dosing will be performed to achieve satisfactory
pain control, up to a maximum daily dosage of 32 mg for hydromorphene and 80 mg for
oxycodone. The primary efficacy outcome will be the determination of the dose of
hydromorphene that produces a level of pain control that is equal to the pain control
provided by oxycodone (equi-analgesic dose). Safety will be monitored throughout the study.
The study hypothesis is that sustained-release hydromorphene taken once daily is well
tolerated and is not inferior with regard to pain control to controlled-release oxycodone
taken twice daily.
Sustained-release hydromorphone (8 mg tablets, taken orally once daily) or oxycodone (10 mg
tablets, taken orally twice daily). Individual adjustments in dosing performed to achieve
satisfactory pain control over 24 weeks. Maximal allowed daily dose is 32 mg for
hydromorphone and 80 mg for oxycodone
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
Starting date: March 2006
Last updated: June 29, 2007