Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Janssen Korea, Ltd., Korea |
---|---|
Information provided by: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT00766831 |
The purpose of this study is to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance provoked by cancer pain.
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: Hydromorphone Hydrochloride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance |
Estimated Enrollment: | 134 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
Korea, Republic of | |
PuSan, Korea, Republic of | |
UlSan, Korea, Republic of | |
JinJu, Korea, Republic of |
Study Director: | Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd., Korea |
Responsible Party: | Janssen Korea, Ltd., Korea ( Medical Director ) |
Study ID Numbers: | CR014806 |
Study First Received: | October 3, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00766831 |
Health Authority: | Korea: Food and Drug Administration |
Cancer pain Numeric Rating scale Sleep Disturbance Hydromorphone |
Hydromorphone Dyssomnias Sleep Disorders Pain |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |