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Evaluation of Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients.

Information source: Janssen Korea, Ltd., Korea
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Hydromorphone Hydrochloride (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Summary

The purpose of this study is to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance provoked by cancer pain.

Clinical Details

Official title: Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

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

Primary outcome: Improvement of the degree of sleep disturbance as measured by the K-BPI (question 9)

Secondary outcome: K-BPI (Korean Brief Pain Inventory: 9-questionnaire, 11-point scale), Pain intensity at AM & PM, Number of breakthrough pain medication, Investigator and patient global assessments: 5-pint rating scale, Patient's preference, CGI-I (Clinical Global

Detailed description: Effective pain relief and high sleep quality allow patients to resume active lives and be themselves. This is multicenter, prospective, open-label, single-arm, dose-ascending study to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance provoked by cancer pain. Patient who took oral opioid previously will be administered the study drug for two weeks. Primary Endpoint is improvement of the degree of sleep disturbance as measured by the K-BPI (question 9). Secondary Endpoint are as follows: K-BPI (Korean Brief Pain Inventory: 9-questionnaire, 11-point scale), Pain intensity at morning and afternoon, Number of breakthrough pain medication, Investigator and patient global assessments: 5-pint rating scale, Patient's preference, CGI-I (Clinical Global

Impression - Improvement: 7 point rating scale), Safety evaluation(adverse event &

tolerance) Initial Dose of Hydromorphone OROS: At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion table. Subject will administer hydromorphone at 10 AM. At Change of Hydromorphone dose: The investigator will increase a patient's daily dose if more than 3 breakthrough pain episodes requiring rescue medication occurred within 24 hours. Daily doses will be titrated up to the next higher dose level every 2 days after phone call

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who are currently receiving strong opioid analgesic for their cancer pain

management

- Patients who are able, in the opinion of investigator, to comply fully with the trial

requirements including completion of the Korean-Brief Pain Inventory

- Patients who have signed an informed consent form

Exclusion Criteria:

- Patients with pain that was not considered to be potentially responsive to opioids

- A recent (within the past 6 months) or currently history of drug and/or alcohol abuse

- Women of childbearing potential who are pregnant or lactating, seeking pregnancy, or

failing to take adequate contraceptive precautions

- Patients with an intolerant of, or hypersensitivity to, hydromorphone or other

opioids

- Patients with GI disease of sufficient severity to be likely to interfere with oral

analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within 5 days of the study, severe gut narrowing or factors predisposing to gut narrowing (both hereditary or iatrogenic [e. g. GI surgery or GI radiotherapy]) that may affect the absorption or transit of orally administered drugs, particularly the insoluble OROS outer coating

- Patients who were receiving or had received monoamine oxidase inhibitors (MAOIs)

within the past 2 weeks

- Patients who had previously enrolled in this trial

- Patients who had participate in another trial with an investigational drug in the

last 4 weeks

- Patients in whom the risks of treatment with morphine/hydromorphone outweighed the

potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders, and Addison's disease.

Locations and Contacts

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Additional Information

Starting date: October 2008
Last updated: September 16, 2010

Page last updated: October 04, 2010

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