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The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve conduction measurements; Pain scores from patient diaries |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change |
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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 | Hot Springs | Arkansas | 71913 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31802967 | Derived | Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019. | |
| 30521533 |
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| La Jolla |
| California |
| 92037 |
| United States |
| Pfizer Investigational Site | Torrance | California | 90502 | United States |
| Pfizer Investigational Site | Torrance | California | 90509 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80218 | United States |
| Pfizer Investigational Site | Lake Worth | Florida | 33462 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Palm Beach Gardens | Florida | 33410 | United States |
| Pfizer Investigational Site | Sunrise | Florida | 33351-6637 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68116 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Englewood | New Jersey | 07631 | United States |
| Pfizer Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| Pfizer Investigational Site | New Brunswick | New Jersey | 08903 | United States |
| Pfizer Investigational Site | Albany | New York | 12205 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | Rochester | New York | 14642 | United States |
| Pfizer Investigational Site | Greenville | North Carolina | 27834 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75214 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Derived |
| Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018. |
| 30206821 | Derived | Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11. |
| 30084288 | Derived | Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20. |
| 27611736 | Derived | Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1. |
| 18796160 | Derived | Arezzo JC, Rosenstock J, Lamoreaux L, Pauer L. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol. 2008 Sep 16;8:33. doi: 10.1186/1471-2377-8-33. |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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