Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
Summary
The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" [a controlled release oral medication delivery system in the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.
Description
This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Cancer Pain
Intervention
OROS hydromorphone
Location
Cheonan
Korea, Republic of
Status
Completed
Source
Janssen Korea, Ltd., Korea
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01621100
- Information obtained from ClinicalTrials.gov on April 17, 2013
Medical and Biotech [MESH] Definitions
Pain, Referred
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.
Facial Pain
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.
Seer Program
A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)
Hydromorphone
An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.
Complex Regional Pain Syndromes
Conditions characterized by pain involving an extremity or other body region, HYPERESTHESIA, and localized autonomic dysfunction following injury to soft tissue or nerve. The pain is usually associated with ERYTHEMA; SKIN TEMPERATURE changes, abnormal sudomotor activity (i.e., changes in sweating due to altered sympathetic innervation) or edema. The degree of pain and other manifestations is out of proportion to that expected from the inciting event. Two subtypes of this condition have been described: type I; (REFLEX SYMPATHETIC DYSTROPHY) and type II; (CAUSALGIA). (From Pain 1995 Oct;63(1):127-33)
Clinical Trials
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...
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 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...
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
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
INTRODUCTION: Strong opioids are efficient drugs for treating chronic pain. In cancer patients, strong opioids are the mainstay of pain management, but in non-cancer pain caution is advised due to pos...
The use of high doses of OROS hydromorphone in an acute palliative care unit.
Abstract Objectives: To characterize patients who received high doses of OROS hydromorphone (OROD-HY), a retrospective study of patients admitted in an acute pain relief and palliative care unit...
Objective: Opioids are recommended for patients with moderate to severe pain due to osteoarthritis (OA), who do not receive adequate analgesia from nonopioid treatment. The objective of this study...
OBJECTIVE: To determine the effect of a lower starting dose of OROS® hydromorphone compared with a higher starting dose. DESIGN: Data from the first 15 days of treatment were compared in a combined a...
PURPOSE: The effectiveness of an opioid rotation to parenteral hydromorphone in advanced cancer patients has never been investigated. Therefore, the purpose of this study was to investigate the analge...
