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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002399-18 | EudraCT Number |
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The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116517 | Experimental | V116517 aqueous suspension; 300 mg |
|
| Celecoxib | Active Comparator | Celecoxib capsules; 400 mg (2 capsules of 200 mg each) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116517 aqueous suspension | Drug | 300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application | Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm | 3.5 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Heat Pain Threshold (HPTr) | Mean temperature in degrees Celsius (°C) | 3.5 hours post-dose |
| Heat Pain tolerance threshold (HPTolTr) | Mean temperature in degrees Celsius (°C) |
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Inclusion Criteria include:
Exclusion Criteria include:
Other protocol-specific inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCBR A/S | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celecoxib capsules | Drug | 400 mg (2 capsules of 200 mg each) taken orally x 1 dose |
|
|
| Placebo | Drug | Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose |
|
| Capsaicin | Drug | 1% administered topically |
|
| Pre-dose and 3.5 hours post-dose |
| Pressure Pain Threshold (PPTr) | Mean pressure kPA | 3.5 hours post-dose |
| Pressure Pain tolerance threshold (PPTolTr) | Mean pressure kPA | 3.5 hours post-dose |
| Peripheral nociceptor activation using Laser Doppler flowmetry | Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging | 3.5 hours post-dose |
| Erythema at the treated area using Erythema index | Erythema at the treated area will be assessed using colorimetry | 3.5 hours post-dose |
| Stimulus-response function to graded von Frey hair stimulation | The mean pain intensity of the stimulations on a '0-10' visual analog scale (VAS), where '0' indicates ''no pain" and '10' indicates '' the most intense pain imaginable'' | 3.5 hours post-dose |
| Secondary pin-prick hyperalgesic area | The area will be assessed using a 60 g weighted von Frey hair, and subjects are asked to report when the sensation changes to a "different sensation", "unpleasant" or "burning pain" sensation | 3.5 hours post-dose |
| Evaluation of change in body temperature | Oral temperature in degrees Celsius (˚C) | Pre-dose and up to 72 hours post-dose |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053284 | Polyunsaturated Alkamides |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D002396 | Catechols |
| D010636 | Phenols |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |