Status:
COMPLETED
Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.
Lead Sponsor:
Janssen-Cilag A.G., Switzerland
Conditions:
Pain
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The primary objective of this pilot trial is to identify pain model(s) which allow(s) to compare and differentiate the analgesic effects between transdermal fentanyl 25µg/h, transdermal fentanyl 12µ...
Detailed Description
After having read and signed the written informed consent form, patients will participate in a screening visit (within 2 weeks before study start, see above selection of study participants). Patients ...
Eligibility Criteria
Inclusion
- Healthy on the basis of a pre-study physical examination
- Subjects who are willing to be hospitalized
- subjects who are willing and able to participate in the pain tests and show responsive pain pattern
Exclusion
- History or presence of liver or renal insufficiency
- acute liver inflammation, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, psychiatric or metabolic disturbances
- severe restriction of respiratory function
- treatment with MAO inhibitors during the last four weeks
- active skin disease or skin irritation at designated patch locations
- history of chronic pain (episodes of more than three months of chronic pain)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00886002
Start Date
November 1 2004
End Date
January 1 2005
Last Update
June 22 2010
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