An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)
Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: OROS hydromorphone HCL ; OxyContin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
Summary
The purpose of this study was to characterize the effectiveness and safety of OROS
hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or
hip who are receiving chronic nonsteroidal anti-inflammatory drug (NSAID) or other
nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.
Clinical Details
Official title: A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in Patients With Chronic Osteoarthritis
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Two primary efficacy:The mean pain relief score at endpoint during the Maintenance Phase. The day from study medication initiation to the third day of moderate to complete pain relief on the final titrated dose during all three phases.
Detailed description:
This was a multicenter, open-label, randomized (patients are assigned different treatments
based on chance), dose-titration, parallel-group study characterizing the effectiveness and
safety of OROS hydromorphone HCL and OxyContin in adult patients with osteoarthritis (OA) of
the knee or hip who were unable to consistently control or treat their osteoarthritis pain
with non opioid medications or with as-needed use of an opioid analgesic. The study
consisted of a 14-day period for randomization, dose-titration, and stabilization, followed
by a 4-week maintenance phase. Eligible patients were randomized equally to begin therapy
with either OROS hydromorphone HCL 8 mg daily or OxyContin 10 mg twice daily. Upward dose
titration (doses with increase in titration) from the starting doses was allowed every 2
days, based on pain relief and opioid-related side effects. The dose was to have been
titrated to provide the best balance between pain relief and side effects. After 14 days, if
therapeutic efficacy with dose stabilization had been documented, the patient was allowed to
begin the 4-week maintenance phase. The expected primary efficacy variable endpoints were:
The mean pain relief score at endpoint defined as the mean of the last 2 non missing pain
relief scores during the Maintenance Phase, and the days from study medication initiation to
the third day of moderate to complete pain relief on the patient's final titrated dose (as
reported in the patient diary) during the Randomization, Titration and Stabilization Phase.
Safety was evaluated by adverse events (AEs), vital signs, and physical examinations.
OROS hydromorphone HCL 8mg tablet orally daily or OxyContin 10mg tablet orally daily; Upward
dose titration from the starting doses was allowed every 2 days, based on pain relief and
opioid-related side effects; After 14 days of efficacy with dose stabilization, patient was
allowed to begin the 4 week maintenance phase.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient who met criteria (functional Class I-III in the hip or knee) for
osteoarthritis for at least 3 months before enrollment
- Patient who had moderate to severe chronic pain despite regular use and stable doses
of an NSAID (nonsteroidal anti-inflammatory drug) or an NSAID with opioid analgesic
taken as needed but not on a daily basis for the treatment of osteoarthritis
Exclusion Criteria:
- Patient intolerant of or hypersensitive to hydromorphone or oxycodone
- Patient of childbearing potential must use medically recognized contraceptive program
before and during the study
- Pregnant or breastfeeding
- Patient who had prior joint replacement of the target knee or hip
- Patient with significant respiratory compromise or depressed ventilatory function
- Patient who was known active drug abuser or alcoholics
Locations and Contacts
Additional Information
Abstract of Clinical Therapeutics article from Science Direct
Ending date: May 2001
Last updated: April 24, 2008
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