Status:
COMPLETED
Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain, Intractable
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to verify the effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in Japanese patients...
Detailed Description
Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, it is not liable to leakage of drug solution and does not contain alcohol, wh...
Eligibility Criteria
Inclusion
- Patients with cancer pain receiving any of the following treatments constantly for at least 3days before the treatment period :(1)Morphine preparations equivalent to less than 45 mg/day of oral morphine (or less than 30 mg/day of suppositories, or less than 15 mg/day of injectable preparations), (2)oral oxycodone preparations equivalent to less than 30 mg/day, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day
- Patients with a pain intensity of less than or equal to 34 mm on the 100 mm Visual Analogue Scale (VAS)
- Patients with an established diagnosis of cancer of any type who have been notified of the disease
- Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patch (patients may be ambulatory after the initial patch has been replaced with the second dose)
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 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 :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00216658
Start Date
December 1 2004
End Date
September 1 2005
Last Update
January 24 2011
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