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Sponsored by: |
Janssen Korea, Ltd., Korea |
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Information provided by: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT00797017 |
Drug class: FDA classfication - Class 'C', The primary objective of this study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-Related Pain: Multicenter, Open Label, Prospective, Observational Study |
Estimated Enrollment: | 1279 |
This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8. Each patients will be evaluated their pain intensity every 28 days during 8 weeks. The secondary objectives are to observe the improvement of the following variable after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities In addition, Investigator and patient global assessment, patient's preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated.
start with 12mcg/h and flexible dose depending on patient's pain relief, treatment period: 56 days
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 |
Study Director: | Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd., Korea |
Study ID Numbers: | CR015409 |
Study First Received: | November 20, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00797017 |
Health Authority: | Korea: Food and Drug Administration |
Chronic Pain Fentanyl Matrix Spinal disorder-related pain |
Spinal Diseases Signs and Symptoms Fentanyl Musculoskeletal Diseases Neurologic Manifestations |
Low Back Pain Pain Bone Diseases Back Pain |
Anesthetics, Intravenous Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |