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The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin (Lyrica) | Drug | Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS) | Weeks 1 and 2 and end of treatment | |
| Change from baseline in weekly mean pain scores | Weeks 1 and 2 and end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores | End of treatment | |
| Adverse events and laboratory value changes | Weeks 1 and 2 and end of treatment | |
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Inclusion criteria:
Exclusion criteria:
(none)
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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 | Bangalore | Karnataka | 560054 | India | ||
| 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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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Change from baseline in weekly mean sleep interference score |
| Weeks 1 and 2 and end of treatment |
| Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ | Weeks 1 and 2 and end of treatment |
| Change from baseline in Patient Global Impression of Change (PGIC) | Weeks 1 and 2 and end of treatment |
| Change from baseline in Clinical Global Impression of Change (CGIC) | Weeks 1 and 2 and end of treatment |
| Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form | End of treatment |
| Bangalore |
| Karnataka / India |
| 560 034 |
| India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 012 | India |
| Pfizer Investigational Site | Maharashtra | Mumbai | 400 007 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 004 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 013 | India |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |