A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis

2014-08-27 03:41:07 | BioPortfolio


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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Osteoarthritis, Hip


OROS hydromorphone HCI (slow release)




Alza Corporation, DE, USA

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:41:07-0400

Clinical Trials [1715 Associated Clinical Trials listed on BioPortfolio]

Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

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...

A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain

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...

Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

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...

A Double-Blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic OA Pain

To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg

The primary objective of this study was to examine the OROS® Hydromorphone HCL pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile for dose propor...

PubMed Articles [5598 Associated PubMed Articles listed on BioPortfolio]

Sustained-Release Hydromorphone Microparticles Produced by Supercritical Fluid Polymer Encapsulation.

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 Year in Review 2018: Clinical.

Osteoarthritis (OA) is the most common joint disease in the world, with an age-associated increase in both incidence and prevalence. Clinical and epidemiologic research is crucial to better understand...

Trends in and predictors of hydromorphone administration in US emergency departments (2007-2014).

To examine recent trends in and predictors of hydromorphone administration in US emergency departments (EDs) compared with other opioids.

A basic fibroblast growth factor slow-release system combined to a biodegradable nerve conduit improves endothelial cell and Schwann cell proliferation: A preliminary study in a rat model.

A basic fibroblast growth factor (bFGF) slow-release system was combined to a biodegradable nerve conduit with the hypothesis this slow-release system would increase the capacity to promote nerve vasc...

The Phenotypic Approach to Osteoarthritis: A Look at Metabolic Syndrome-Associated Osteoarthritis.

Metabolic syndrome-associated osteoarthritis (Met-OA) is a clinical phenotype defined by the role of obesity and metabolic syndrome as risk factors and by chronic low-grade inflammation. Obesity is an...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis"

Quick Search


Relevant Topics

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...

Drug Discovery
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. ...

Searches Linking to this Trial