Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

NCT00143156 | Completed Phase 3

• 1 other identifier: A0081071
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 54

Brief Summary

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Secondary Outcomes (1)

• End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Interventions

pregabalin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females at least 18 years of age, of any ethnic origin
• Type 1 or 2 diabetes mellitus
• Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

You may not qualify if:

• Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
• 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.

Sponsors & Collaborators

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

Study Sites (54)

Pfizer Investigational Site

Tuscaloosa, Alabama, 35406, United States

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Phoenix, Arizona, 85023, United States

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Little Rock, Arkansas, 72205, United States

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La Mesa, California, 91942, United States

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Los Gatos, California, 95032-3739, United States

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Northridge, California, 91325, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Boulder, Colorado, 80304, United States

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Wheat Ridge, Colorado, 80033, United States

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New Haven, Connecticut, 06510, United States

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Clearwater, Florida, 33761, United States

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Hollywood, Florida, 33021, United States

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Ocala, Florida, 34471, United States

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Tampa, Florida, 33606, United States

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West Palm Beach, Florida, 33407-2450, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30327, United States

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Decatur, Georgia, 30033, United States

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Chicago, Illinois, 60610, United States

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Chicago, Illinois, 60612, United States

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Peoria, Illinois, 61602, United States

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Springfield, Illinois, 62704, United States

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Indianapolis, Indiana, 46250, United States

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Lexington, Kentucky, 40503, United States

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Baltimore, Maryland, 21204, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02215, United States

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Springfield, Massachusetts, 01104, United States

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Jackson, Mississippi, 39202, United States

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Tupelo, Mississippi, 38803-4087, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68116-6465, United States

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Englewood, New Jersey, 07631, United States

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Shrewsbury, New Jersey, 07702, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10022-1009, United States

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New York, New York, 10032, United States

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Kettering, Ohio, 45429, United States

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Toledo, Ohio, 43623, United States

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Tulsa, Oklahoma, 74104-5428, United States

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Warwick, Rhode Island, 02886, United States

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Memphis, Tennessee, 38119, United States

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Dallas, Texas, 75390-8858, United States

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Frisco, Texas, 75034, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78207, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84108, United States

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Burlington, Vermont, 05401, United States

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Pfizer Investigational Site

Charlottesville, Virginia, 22908, United States

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Pfizer Investigational Site

Ponce, 00716, Puerto Rico

Location

Related Publications (5)

• 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.

  PMID: 31802967 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.

  PMID: 30521533 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.

  PMID: 30206821 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.

  PMID: 30084288 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.

  PMID: 27611736 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2005
• Study Completion: May 1, 2007
• Last Updated: January 22, 2021

Record last verified: 2008-04

Locations

US (53); PR (1)