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PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized cross-over sequence | Other | Randomized unbalanced sequence of incomplete block design with replicates within sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04531083 100mg | Drug | Oral PF-04531083 100mg suspension single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours. | 24 hours | |
| Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| PF-04531083 2000mg |
| Drug |
Oral PF-04531083 2000mg suspension single dose |
|
| Placebo suspension | Drug | Oral Placebo suspension (matched to PF-04531083 suspension) |
|
| Placebo tablet | Drug | Oral Placebo tablet (matched to Oxycodone) |
|
| Oxycodone 20mg | Drug | Oral Oxycodone 20mg (Oxycontin) controlled release formulation |
|
| Summary of plasma concentrations of PF-04531083 | 24 hours |
| Exploratory colorimetric data collected from baseline and MED test exposure areas | 24 hours |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |