A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

NCT00156078 | Completed Phase 4

• 1 other identifier: A0081030
• Study Type: interventional
• Target: 450
• Locations: 19 countries
• Sites: 34

Brief Summary

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

• Mean pain score

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:

• Diagnosis of Type 1 or 2 diabetes mellitus.
• Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

You may not qualify if:

• Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
• Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

Sponsors & Collaborators

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

Study Sites (35)

Pfizer Investigational Site

Buenos Aires, Argentina

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Location

Pfizer Investigational Site

Niterói, Rio de Janeiro, Brazil

Location

Pfizer Investigational Site

Valparaíso, Región de Valparaíso, Chile

Location

Pfizer Investigational Site

Providencia, Santiago Metropolitan, Chile

Location

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Location

Pfizer Investigational Site

Bogotá, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

Jakarta Pusat, Indonesia

Location

Pfizer Investigational Site

Surabaya, Indonesia

Location

Pfizer Investigational Site

Amman, Jordan

Location

Pfizer Investigational Site

Beirut, Lebanon

Location

Pfizer Investigational Site

Kuala Lumpur, Malaysia

Location

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico

Location

Pfizer Investigational Site

San Luis Potosí City, Mexico

Location

Pfizer Investigational Site

España, Manila, Philippines

Location

Pfizer Investigational Site

Quezon City, Philippines

Location

Pfizer Investigational Site

Riyadh, Saudi Arabia

Location

Pfizer Investigational Site

Singapore, Singapore

Location

Pfizer Investigational Site

Pusan, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Pfizer Investigational Site

Gueishan Shiang, Taoyan Hsien, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Pfizer Investigational Site

Khet Rajathevee, Bangkok, Thailand

Location

Pfizer Investigational Site

Muang, Chiang Mai, Thailand

Location

Pfizer Investigational Site

Çapa, Istanbul, Turkey (Türkiye)

Location

Pfizer Investigational Site

Ankara, Turkey (Türkiye)

Location

Pfizer Investigational Site

Istanbul, Turkey (Türkiye)

Location

Pfizer Investigational Site

Izmir, Turkey (Türkiye)

Location

Pfizer Investigational Site

Mersin, Turkey (Türkiye)

Location

Pfizer Investigational Site

Abu Dhabi, United Arab Emirates

Location

Pfizer Investigational Site

El Hatillo Municipality, Caracas-Estado Miranda, Venezuela

Location

Pfizer Investigational Site

Caracas, Distrito Federal, Venezuela

Location

Pfizer Investigational Site

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2005
• Study Completion: May 1, 2007
• Last Updated: January 25, 2021

Record last verified: 2008-03

Locations

AR (1); MY (1); BR (2); TW (2); JO (1); LE (1); TU (5); VE (2); CO (2); TH (2); KR (2); SG (1); ME (3); SA (1); AE (1); ID (2); CL (2); EC (1); PH (2)