Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain
This study has been completed.
Sponsor:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00797017
First received: November 20, 2008
Last updated: April 24, 2014
Last verified: April 2014
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Purpose
The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: fentanyl |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study |
Resource links provided by NLM:
Further study details as provided by Janssen Korea, Ltd., Korea:
Primary Outcome Measures:
- Pain intensity with Numeric Rating Scale [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Impact of activity of daily living and social activities [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
- Investigator and patient global assessment [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
- CGI-I (Clinical Global Impression) [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
- K-ODI (Korean version of Oswestry Disability Index) [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
- Improvement of sleep disturbance [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
| Enrollment: | 1576 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Drug: fentanyl
Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
|
| 002 |
Drug: fentanyl
(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)
|
| 003 |
Drug: fentanyl
Bone Fracture, starting with 12mcg/h (flexible dose)
|
| 004 |
Drug: fentanyl
(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)
|
| 005 |
Drug: fentanyl
Infection, starting with 12mcg/h (flexible dose)
|
| 006 |
Drug: fentanyl
(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)
|
| 007 |
Drug: fentanyl
Other Deformity, starting with 12mcg/h (flexible dose)
|
Detailed Description:
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 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables 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 preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients who had unsatisfactory treatment with previous medication (severe pain: NRS = 7) and no experience with fentanyl matrix will be eligible
Criteria
Inclusion Criteria:
- Patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer
- Patients who can fully observe the overall clinical study requirements including K-ODI completion at the investigator's discretion
- Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
- Patients who have never been administered fentanyl matrix over the last one month
Exclusion Criteria:
- Patients with a history of the drug or alcohol abuse in the past or now
- Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
- Patients who are unable to use a transdermal system due to skin disease
- Patients with serious mental disorder
- Patients with history of hypersensitivity to opioid analgesics
- Patients with history of CO2 retention
- Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797017
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797017
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
| Study Director: | Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. |
More Information
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT00797017 History of Changes |
| Other Study ID Numbers: | CR015409 |
| Study First Received: | November 20, 2008 |
| Last Updated: | April 24, 2014 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Chronic Pain Fentanyl Matrix Spinal disorder-related pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Spinal Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bone Diseases Musculoskeletal Diseases Fentanyl Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on September 23, 2016