drugset / Trial / NCT00886002

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

NCT00886002

Phase 1 Completed 20 enrolled Janssen-Cilag A.G., Switzerland
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2004-11
Primary completion
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 35 ug Other
Subject Fentanyl Other / unclassified 12 ug Other
Subject Fentanyl Other / unclassified 25 ug Other
Background Naloxone Small molecule

Indications

No indication recorded.