Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT00143156
Last Updated: 2021-01-22
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
PHASE3
450 participants
INTERVENTIONAL
2005-03-31
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
* Type 1 or 2 diabetes mellitus
* Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
Exclusion Criteria
* Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
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
Tuscaloosa, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
La Mesa, California, United States
Pfizer Investigational Site
Los Gatos, California, United States
Pfizer Investigational Site
Northridge, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Springfield, Illinois, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Springfield, Massachusetts, United States
Pfizer Investigational Site
Jackson, Mississippi, United States
Pfizer Investigational Site
Tupelo, Mississippi, United States
Pfizer Investigational Site
Jefferson City, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Englewood, New Jersey, United States
Pfizer Investigational Site
Shrewsbury, New Jersey, United States
Pfizer Investigational Site
New Hyde Park, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Kettering, Ohio, United States
Pfizer Investigational Site
Toledo, Ohio, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Warwick, Rhode Island, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Frisco, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Burlington, Vermont, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Ponce, , Puerto Rico
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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A0081071
Identifier Type: -
Identifier Source: org_study_id
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