A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain
This is a randomized (patients assigned by chance to receive 1 of 2 study drugs),
double-blind (neither the patient nor the investigator will know the identity of the
assigned treatment) study in China to evaluate the safety and efficacy of OROS hydromorphone
hydrochloride (HCl) administered once-daily compared with oxycodone HCl controlled-release
(CR) administered twice daily in adult patients with cancer pain who require the use of
strong oral opioid (narcotic) analgesics (pain relievers related to morphine). The study
consists of a screening period of up to 14 days before treatment to determine patient
eligibility for the study. Approximately 260 adult patients meeting entry criteria will
enter the dosage titration period of the study and over a period of 2 to 8 days will be
converted from their current opioid medication to an appropriate dosage of study drug (OROS
hydromorphone HCl or oxycodone CR HCl). To prevent the investigator and the patient from
knowing the assigned treatment, 2 capsules of study drug and/or dummy placebo will be
self-administered by all patients twice daily at 12-hour intervals. Dummy placebo capsules
will be identical in appearance to capsules of study drug but will not contain active drug.
Once an appropriate starting dosage of study drug is determined for a patient, the patient
will be treated for 28 days (referred to as the maintenance period of the study). Patients
will be instructed to take study drug (includes dummy placebo capsules) orally (by mouth)
twice daily beginning in the morning (doses are to be taken once every 12 hours). Patients
will be required to report to the study clinic for up to 10 times during the study to have
required study procedures and laboratory tests performed (additional visits may be
required). During the 28 day treatment period (referred to as the maintenance period of the
study), patients may have their dosage of study drug adjusted (increased or decreased) to
obtain the best balance between pain relief and opioid-related side effects. If patients
experience sudden episodes of pain (referred to as Breakthrough pain) during treatment with
study drug (ie, during the time between doses) they will be permitted to take a single oral
dose of morphine hydrochloride every 4 hours as needed to control the pain. During the
study, pain experienced by patients will be assessed by the use of a questionnaire (referred
to as the Brief Pain Inventory [BPI] Short Form) that will rate pain on a scale of 0 to 10
where a score of 0 is no pain and a score of 10 is pain as bad as you can imagine. In
addition, patient safety will be assessed during treatment by monitoring for adverse events
and by evaluating results obtained from clinical laboratory tests, electrocardiograms, vital
signs measurements and physical examinations. Two capsules containing tablets of study drug
and/or dummy placebo will be self-administered orally, twice daily, at 12-hr intervals by
patients for up to 36 days. Patients will receive treatment with either OROS hydromorphone
HCL at a starting dosage of 8mg/day to be increased up to a maximum total daily dosage of
32mg/day OR patients will receive oxycodone HCL CR at a starting dosage of 10mg twice daily
to be increased to a maximum total daily dosage of 80mg (ie, 40mg twice daily).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Patient assessment of pain at its worst in the last 24 hours, included as an item in the Brief Pain Inventory (BPI) Short Form, where 0=no pain and 10=pain as bad as you can imagine.
At endpoint (the last recorded value obtained up to the end of the study (Day 29 +/-1 day)
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board
CR017437
NCT01205126
December 2009
February 2011
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