A Study of the Effectiveness and Safety of Sustained-Release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

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 (equi-analgesic dosage).

Official title: 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.

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.

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 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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Starting date: March 2006
Last updated: June 29, 2007