Status:
COMPLETED
Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain, Intractable
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, fentanyl transdermal matrix patch is not liable to leakage of drug solution a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00216684
Start Date
May 1 2005
End Date
September 1 2006
Last Update
February 1 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.