Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
NCT ID: NCT00159679
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
167 participants
INTERVENTIONAL
2004-09-30
2005-10-31
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
* Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months
Exclusion Criteria
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
Hot Springs, Arkansas, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Lake Worth, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States
Pfizer Investigational Site
Sunrise, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Englewood, New Jersey, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Greenville, North Carolina, United States
Pfizer Investigational Site
Toledo, Ohio, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
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.
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.
Other Identifiers
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A0081060
Identifier Type: -
Identifier Source: org_study_id
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