The Clinical Usefulness of Hydromorphone HCl ORal Osmotic System in the Reduction of Breakthrough Pain Medication Frequency

2014-08-27 03:18:15 | BioPortfolio


The purpose is to evaluate the clinical efficacy of Hydromorphone HCl ORal Osmotic System by assessing the degree of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl ORal Osmotic System in Korean cancer patients.


This clinical trial consists of patient screening, two- week efficacy and safety evaluation phase and twelve-week extension phase. During the patient selection period, potential patients will take previously administered oral opioid analgesic, and patients eligible for participation in this clinical trial at the second visit will receive the study drug for two weeks. At investigator discretion, patients completing 2 weeks of treatment with study drug can be enrolled into the extension phase. The sample size of this study is 120. The study population is the patients administered with only the oral opioid analgesic for cancer pain treatment, and administered with the immediate opioid analgesic for breakthrough pain more than twice a day on average for the three days prior to the 2nd visit. Efficacy and safety evaluation phase: Potential patients determined for participation in the study during the 1st visit and administered with oral strong opioid analgesic ¿(not the study drug¿) until the 2nd visit and with immediate-release opioid analgesic whenever breakthrough pain is present. From the 2nd visit to the 4rd visit, Hydromorphone HCl Oral Osmotic push-pull System (Oral Osmotic push-pull System: Each Push-Pull hydromorphone tablet comprises a semi-rigid, non-dissolvable membrane enclosing a layered core. A drug layer contains hydromorphone and excipients. A 'push' layer contains osmotic agents. A precision laser-drilled hole serves as the delivery orifice in the GI tract. Fluid flows across the semi-permeable membrane at a controlled rate, causing (1) hydromorphone to go into suspension (2) the osmotic layer to swell. As the expanding osmotic layer pushes against the drug layer, hydrated hydromorphone flows out of the delivery orifice at the same rate as fluid enters the core. The depleted membrane does not dissolve and the shell is excreted intact in the feces. Study drug is administered once a day for two weeks. The dose of study drug is flexible and will increase or decrease based on the frequency of immediate-release opioid analgesic doses needed to manage pain. In the Extension-Safety Evaluation phase, the dose of study drug will be determined by the investigator's discretion based on final dosage at efficacy and safety evaluation phase and patient's condition. If patients want to take study drug for the extension phase after signing the informed consent form, the investigator will collect safety information including adverse events for 12 weeks. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion table (oxycodone 10mg twice/day is equal to hydromorphone HCl 8mg once/day). Fow two weeks (efficacy and safety evaluation phase of the study), patients will take hydromorphone at 10 AM daily. Change of Hydromorphone dose: The investigator will increase a patient's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment




Hydromorphone HCl OROS




Janssen Korea, Ltd., Korea

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:15-0400

Clinical Trials [789 Associated Clinical Trials listed on BioPortfolio]

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

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain convertin...

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 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

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...

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release [IR] and sustained-release [SR] formulations) using the "worst pain i...

PubMed Articles [4076 Associated PubMed Articles listed on BioPortfolio]

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 ...

Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients.

It is unknown whether ketamine administered via patient-controlled analgesia (PCA) provides adequate analgesia while reducing opioid consumption in the traumatically injured patient. Differences in op...

Hydromorphone Conversion Dilemma: A Millennial Problem.

IV prochlorperazine + diphenhydramine improved migraine pain relief more than IV hydromorphone in the ED.

Discordant Umbilical Cord Drug Testing Results in Monozygotic Twins.

Our laboratory received segments of umbilical cord that originated from identical twins for routine toxicology analysis. The specimens were analyzed multiple times by liquid chromatography tandem mass...

Medical and Biotech [MESH] Definitions

A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.

Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.

Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN.

An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.

Acute pain that comes on rapidly despite the use of pain medication.

More From BioPortfolio on "The Clinical Usefulness of Hydromorphone HCl ORal Osmotic System in the Reduction of Breakthrough Pain Medication Frequency"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

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. ...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Searches Linking to this Trial