A Safety and Efficacy Study of OROS Hydromorphone HCL in Patients With Cancer-related Pain

Condition(s) targeted: Pain

Intervention: Hydromorphone HCl (Drug); Oxycodone HCl CR (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the safety and efficacy of OROS hydromorphone hydrochloride (HCL) tablets administered once-daily compared with oxycodone HCL controlled-release tablets administered twice daily in patients with cancer-related pain. OROS hydromorphone HCL and oxycodone HCL are opioid analgesics (ie, narcotic pain-relievers related to morphine).

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

Other assessments of pain severity and pain relief from the BPI (Short Form)

Number of breakthrough pain medication doses taken

Number of patients with treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation from the study

Detailed description: 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).

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Currently receiving strong oral or transdermal (through the skin) opioid analgesics

with inadequate control of moderate to severe cancer pain or currently receiving weak opioids for cancer pain and are eligible according to the study protocol to receive treatment with a strong opioid analgesic

- Require or are expected to require between 40 mg and 184 mg of oral morphine or

morphine equivalents every 24 hours

- Are not expected to start a course of chemotherapy, radiotherapy, target cancer

therapy, hormone therapy or diphosphate 2 weeks prior to randomization or during the study

- If receiving long-term treatment including hormone, target cancer therapy and

diphosphate, the treatment should keep stable as much as possible from 2 weeks before randomization and up to the completion of the study

- Have a life expectancy of 12 weeks or longer

Exclusion Criteria:

- Have pure neuropathic pain, pain of unknown origin, or acute pain

- Have only pain on movement

- Are receiving or have received treatment with medical isotopes within the previous 2

weeks prior to randomization

- Have narrowing (irrespective of cause) of the gastrointestinal tract or have blind

loops of the gastrointestinal tract or gastrointestinal obstruction

- Have any significant central nervous system (CNS) disorder or any disorder that

predisposes the patient to respiratory depression

- Have any condition wherein the risks of treatment with study drug may outweigh the

potential benefits

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Beijing, China; Active, not recruiting

Chengdu, China; Active, not recruiting

Fu Zhou, China; Active, not recruiting

Guangdong, China; Active, not recruiting

Guangzhou, China; Recruiting

Hangzhou, China; Recruiting

Hefei, China; Active, not recruiting

Nanchang, China; Active, not recruiting

Nanning, China; Active, not recruiting

Shanghai, China; Active, not recruiting

Shanghai, China; Recruiting

Tianjin, China; Completed

Wuhan, China; Active, not recruiting

To learn how to participate in this trial please click here.

Starting date: December 2009
Last updated: April 1, 2011