Pain, Intractable Clinical Trial
Official title:
An Open Label Study to Confirm the Effectiveness, and Safety of Fentanyl Transdermal Matrix Patch in Japanese Patients With Chronic Intractable Pain Who Has Prior Therapy of Codeine, Morphine Hydrochloride, or Fentanyl Injectable Preparations.
The purpose of this study is to verify the effectiveness, and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks are to be assessed, if possible.
Status | Completed |
Enrollment | 139 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients with chronic intractable pain receiving any of the following treatments :(1)Codeine phosphate, (2)Morphine hydrochloride preparations equivalent to less than 315 mg/day of oral morphine, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day - Patients with chronic intractable pain in whom lesions causative of pain cannot be removed or treated, or in whom pain has been persisting for at least 12 weeks despite of the existing medication - Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patches (patients may be ambulatory when the study starts). Exclusion Criteria: - Patients with respiratory dysfunction such as chronic pulmonary disease - Patients with asthma - Patients with bradyarrhythmia - Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period - Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor - Patients with any psychoneurologic complication and judged incapable of self assessment - Patients with or with a history of drug dependency or narcotic abuse - Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's global assessments of pain on the completion day of Treatment period 1 | |||
Secondary | Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03887494 -
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
|
N/A | |
Recruiting |
NCT05761392 -
APP-based Precise Management System of Chronic Intractable Pain
|
N/A | |
Suspended |
NCT05067257 -
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
|
Phase 2 | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Withdrawn |
NCT01951911 -
Effectiveness of Ketamine in Malignant Neuropathic Pain Relief
|
Phase 3 | |
Completed |
NCT04701008 -
Efficacy of Ketamine in Post Anesthesia Recovery Room
|
||
Completed |
NCT03350256 -
BurstDR™ micrOdosing stimuLation in De-novo Patients
|
N/A | |
Completed |
NCT04602286 -
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)
|
N/A | |
Completed |
NCT04625504 -
Investigating Biological Targets, Markers, and Intervention for Chronic Pain
|
N/A | |
Recruiting |
NCT05398003 -
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
|
N/A | |
Completed |
NCT02886286 -
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
|
Phase 4 | |
Recruiting |
NCT05775510 -
Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain
|
||
Active, not recruiting |
NCT04727216 -
Intermittent vs. Continuous Dorsal Root Ganglion Stimulation
|
N/A | |
Completed |
NCT02091076 -
Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing
|
Phase 1/Phase 2 | |
Completed |
NCT01166906 -
Pain Blocking During Drug Administration or Blood Collection With Needles
|
||
Recruiting |
NCT04876469 -
Radiocontrast Media in the Pulsed Radiofrequency Treatment
|
N/A | |
Completed |
NCT05108103 -
Determination of Longus Colli Muscle Thickness by Ultrasonography
|
||
Completed |
NCT04727749 -
Pawsitive Impacts of Therapy Dog Visits
|
N/A | |
Completed |
NCT04096391 -
Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population
|
N/A | |
Terminated |
NCT00122915 -
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
|
Phase 3 |