Track topics on Twitter Track topics that are important to you
The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).
This was a phase 3, randomized (patients are assigned different treatments based on chance), placebo-controlled, double-blind, fixed-dose, parallel-group, multicenter study in adult patients with OA (osteoarthritis) who were unable to consistently control or treat their pain with nonopioid medications, or who had received an opioid for treatment of pain. Eligible patients were randomized in an equal ratio to receive 1 of 3 treatments: OROS hydromorphone HCI (slow release) 8mg, OROS hydromorphone HCI (slow release) 16 mg, or placebo (no drug). All patients could take acetaminophen (less than or equal to 2000 mg per day) as rescue medication for osteoarthritic pain. Rescue medication was not permitted during the washout period or 6 hours before an assessment of effectiveness. The study was comprised of the following periods: an analgesic (pain reliever) taper and washout period (less than or equal to 2 weeks), a Titration (increase)Phase (less than or equal to 16 days), a Maintenance Phase (12 weeks), and a study drug taper period (less than or equal to 1 week). At the end of the washout period, all patients received OROS hydromorphone HCI (slow release) 8 mg or matching placebo to be taken once daily. After 1 week, patients were to return to the study site and receive new supplies of study drug. During the second week of titration (increase), patients randomized to the OROS hydromorphone (slow release) 16 mg group had their dose increased from 8 mg daily to 16 mg daily of OROS hydromorphone (slow release). No dose adjustments were allowed. After completing the Maintenance Phase or upon early termination, study drug was tapered for up to 1 week as follows: one 8 mg tablet or placebo once daily for the first 2 days then taken every other day as appropriate to taper off the study medication. Safety assessments of physical examination, vital signs, labs and adverse event reporting were done at baseline, termination throughout the study. The primary measurement was the time-interval weighted area under the curve(AUC) divided by the maximum AUC benefit possible for an individual. The AUC was a measure of cumulative pain intensity differences from baseline for the Titration and Maintenance phases. At termination, patients were assigned their baseline pain value for the remainder of the trial, baseline observation carried forward (BOCF) or the last available pain value for the remainder of the trial, last observation carried forward (LOCF). Western Ontario and McMaster Osteoarthritis Index (WOMAC) overall index score, physical function, joint stiffness subscales were analyzed using the AUC ratio and change from baseline using no imputation, and the baseline observation carried forward (BOCF) and last observation carried forward (LOCF) imputation methods. The medical outcome study (MOS) sleep scale was also analyzed per protocol. OROS hydromorphone (slow release) 8 mg and 16 mg tablets and placebo taken orally once daily for 17 weeks
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
OROS hydromorphone HCI (slow release)
Alza Corporation, DE, USA
Published on BioPortfolio: 2014-08-27T03:41:07-0400
The purpose of this study was to characterize a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of OROS...
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer pa...
The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow...
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
The primary objective of this study was to examine the OROSÂ® Hydromorphone HCL pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile for dose propor...
A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.
Hydromorphone is a standard opioid analgesic for cancer pain that, prior to this study, was not approved in Japan, where options for opioid switching are limited. We aimed to investigate the efficacy ...
To examine theeffects on the brain of 2-month treatment withamethylphenidate extended-release formulation (OROS-MPH) using [Tc-] TRODAT-1SPECT in a sample of treatment-naïve adolescents with Attentio...
Chronic cancer pain remains prevalent and severe for many patients, particularly in those with advanced disease. The effectiveness of analgesic/adjuvant drug treatments in routine practice has changed...
Osteoarthritis is amongst the major causes of disability worldwide, but no medications that can slow or stop progression of this disorder have been identified. Recent evidence suggests roles for a var...
We examined the effect of supplemental dietary slow-release urea on the growth performance and physiological status of 16 dairy Holstein heifers (10 months of age, 322 ± 10 kg). The heifers were ...
Administration of antineoplastic agents together with an embolizing vehicle. This allows slow release of the agent as well as obstruction of the blood supply to the neoplasm.
An anti-infective agent most commonly used in the treatment of urinary tract infections. Its anti-infective action derives from the slow release of formaldehyde by hydrolysis at acidic pH. (From Martindale, The Extra Pharmacopoeia, 30th ed, p173)
An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.
Diseases of viral origin, characterized by incubation periods of months to years, insidious onset of clinical manifestations, and protracted clinical course. Though the disease process is protracted, viral multiplication may not be unusually slow. Conventional viruses produce slow virus diseases such as SUBACUTE SCLEROSING PANENCEPHALITIS, progressive multifocal leukoencephalopathy (LEUKOENCEPHALOPATHY, PROGRESSIVE MULTIFOCAL), and AIDS. Diseases produced by unconventional agents were originally considered part of this group. They are now called PRION DISEASES.
A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...