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This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH-797804 | Drug | 6 mg dose in oral capsule form, once daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PH-797804 pharmacokinetics | Weeks 1, 2, and 4 | |
| Patient global impression of change | Week 4 | |
| Neuropathic Pain Symptom Inventory |
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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 | Viña del Mar | Valparaiso | 2520997 | Chile | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
oral capsule form, once daily for 28 days |
|
| Baseline and Weeks 1, 2, and 4 |
| Moscow |
| 123098 |
| Russia |
| Pfizer Investigational Site | Saint Petersburg | 194175 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194354 | Russia |
| Pfizer Investigational Site | Yaroslavl | 150030 | Russia |
| Pfizer Investigational Site | Cadiz | Cadiz | 11009 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Ourense | Ourense | 32005 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41013 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46014 | Spain |
| Pfizer Investigational Site | Linköping | 581 85 | Sweden |
| Pfizer Investigational Site | Stockholm | 114 54 | Sweden |
| Pfizer Investigational Site | Stockholm | 115 22 | Sweden |
| Pfizer Investigational Site | Dnipropetrovsk | 49616 | Ukraine |
| Pfizer Investigational Site | Donetsk | 83045 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61052 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61068 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61178 | Ukraine |
| Pfizer Investigational Site | Kyiv | 04050 | Ukraine |
| Pfizer Investigational Site | Odesa | 65025 | Ukraine |
| Pfizer Investigational Site | Simferopol | 95006 | Ukraine |
| Pfizer Investigational Site | Bexhill-on-Sea | East Sussex | TN40 1JJ | United Kingdom |
| Pfizer Investigational Site | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| Pfizer Investigational Site | Weybridge | Surrey | KT15 2BH | United Kingdom |
| Pfizer Investigational Site | Solihull | B91 2JL | United Kingdom |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542398 | PH 797804 |
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