Pain Clinical Trial
Official title:
Explorative, Double-blind Study on Dose Effectiveness of DUROGESIC D-Trans 12 Mcg/h and 25mcg/h Compared to Transtec and Placebo in Acute Pain Models in Healthy Volunteers.
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag A.G., Switzerland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The first objective of the trial is to identify which acute pain model differentiates best between placebo and transdermal fentanyl 25µg/h. | |||
Secondary | The second objective is to investigate, whether a significant dosage effect correlation exists in the target model between transdermal fentanyl 25µg/h, 12µg/h and placebo and TRANSTEC 35 mcg/h. |
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