Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.
NCT00886002 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2010-06-22
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.
Conditions
Interventions
- DRUG
-
Fentanyl; Buprenorphine; Naloxone
Sponsors & Collaborators
-
Janssen-Cilag A.G., Switzerland
lead INDUSTRY
Principal Investigators
-
Janssen-Cilag A.G. Clinical Trial · Janssen-Cilag A.G.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Completion
- 2005-01-31
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