A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
NCT ID: NCT00156078
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
450 participants
INTERVENTIONAL
2005-01-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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pregabalin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
Exclusion Criteria
* Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site
Niterói, Rio de Janeiro, Brazil
Pfizer Investigational Site
Valparaíso, Región de Valparaíso, Chile
Pfizer Investigational Site
Providencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Medellín, Antioquia, Colombia
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Pfizer Investigational Site
Jakarta Pusat, , Indonesia
Pfizer Investigational Site
Surabaya, , Indonesia
Pfizer Investigational Site
Amman, , Jordan
Pfizer Investigational Site
Beirut, , Lebanon
Pfizer Investigational Site
Kuala Lumpur, , Malaysia
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Mexico City, , Mexico
Pfizer Investigational Site
San Luis Potosí City, , Mexico
Pfizer Investigational Site
España, Manila, Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Riyadh, , Saudi Arabia
Pfizer Investigational Site
Singapore, , Singapore
Pfizer Investigational Site
Pusan, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Gueishan Shiang, Taoyan Hsien, Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Khet Rajathevee, Bangkok, Thailand
Pfizer Investigational Site
Muang, Chiang Mai, Thailand
Pfizer Investigational Site
Çapa, Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, , Turkey (Türkiye)
Pfizer Investigational Site
Izmir, , Turkey (Türkiye)
Pfizer Investigational Site
Mersin, , Turkey (Türkiye)
Pfizer Investigational Site
Abu Dhabi, , United Arab Emirates
Pfizer Investigational Site
El Hatillo Municipality, Caracas-Estado Miranda, Venezuela
Pfizer Investigational Site
Caracas, Distrito Federal, Venezuela
Pfizer Investigational Site
, ,
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081030
Identifier Type: -
Identifier Source: org_study_id
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