Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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 12µg/h and placebo in a dose dependent way. The second objective is to compare the effects of transdermal buprenorphine 35µg/h in these models with the effect of the two transdermal fentanyl dosages. Therefore four different treatments are given; all treatments will be by means of a patch that is attached to the back for 72 hours.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag A.G., Switzerland
• Treatments: Buprenorphine; Fentanyl; Naloxone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)