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The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Placebo Comparator |
| |
| Sequence 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-weeks placebo then gabapentin | Drug | Placebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS) | Weeks 2 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject assessed quality of evoked pain for punctate allodynia | Weeks 2 and 4 | |
| Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush) | Weeks 2 and 4 | |
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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 | Liverpool | L9 7AL | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 1-week placebo then gabapentin | Drug | Placebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks |
|
| Pressure pain tolerance threshold |
| Weeks 2 and 4 |
| Pain NRS scores for pressure pain | Weeks 2 and 4 |
| Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush) | Weeks 2 and 4 |
| Tactile threshold | Week 4 |
| Pressure pain detection threshold | Weeks 2 and 4 |
| Area of punctate and dynamic (soft and coarse brush) allodynia | Weeks 2 and 4 |
| Pain NRS score for punctate allodynia | Weeks 2 and 4 |
| Pain NRS scores for temporal summation to punctate stimuli | Weeks 2 and 4 |
| Subject assessed quality of evoked pain for temporal summation to punctate stimuli | Weeks 2 and 4 |
| Neuropathic pain scale | Week 4 |
| Test-day global pain scale | Week 4 |
| Pain diary card | Week 4 |
| Pain NRS score for dynamic brush allodynia (soft brush) | Weeks 2 and 4 |
| Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush) | Weeks 2 and 4 |
| Presence of metabonomic biomarkers | Weeks 1 and 4 |
| Physical examination | 1 week after 4-week treatment period |
| Adverse events | Throughout study duration |
| Clinical laboratory tests | 1 week after 4-week treatment period |
| Subject assessed quality of pressure pain | Weeks 2 and 4 |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| 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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