Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00159679

Recruitment Status : Completed

First Posted : September 12, 2005

Last Update Posted : January 25, 2021

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Neuropathy, Painful	Drug: Pregabalin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	167 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Study Start Date :	September 2004
Actual Study Completion Date :	October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Nerve conduction measurements; Pain scores from patient diaries

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with Type 1 or 2 diabetes
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:

Patients must not be in poor or unstable health.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159679

Locations

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United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Torrance, California, United States, 90502
Pfizer Investigational Site
Torrance, California, United States, 90509
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
Pfizer Investigational Site
Lake Worth, Florida, United States, 33462
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Pfizer Investigational Site
Sunrise, Florida, United States, 33351-6637
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68116
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Englewood, New Jersey, United States, 07631
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12205
Pfizer Investigational Site
Rochester, New York, United States, 14618
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75214
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: PLoS One. 2019 Feb 26;14(2):e0212959.

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.

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Responsible Party:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:	NCT00159679
Other Study ID Numbers:	A0081060
First Posted:	September 12, 2005 Key Record Dates
Last Update Posted:	January 25, 2021
Last Verified:	April 2009

Additional relevant MeSH terms:

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Peripheral Nervous System Diseases Diabetic Neuropathies Pain Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pregabalin Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

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