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

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Mean pain score

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00156078
Brief Title
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
Official Title
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pregabalin
Primary Outcome Measure Information:
Title
Mean pain score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Type 1 or 2 diabetes mellitus. Diagnosis of painful DPN for at least 12 months but less than 5 years in duration. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Niteroi
State/Province
RJ
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Valparaiso
State/Province
V Region
Country
Chile
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Jakarta Pusat
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Surabaya
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Amman
Country
Jordan
Facility Name
Pfizer Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Beirut
Country
Lebanon
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico Df
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Espana
State/Province
Manila
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Riyadh
Country
Saudi Arabia
Facility Name
Pfizer Investigational Site
City
Singapore
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Gueishan Shiang
State/Province
Taoyan Hsien
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Khet Rajathevee
State/Province
Bangkok
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Chiang MAI
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Capa
State/Province
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Mersin
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Abu Dhabi
Country
United Arab Emirates
Facility Name
Pfizer Investigational Site
City
El Hatillo
State/Province
Caracas-Estado Miranda
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Distrito Capital
Country
Venezuela
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Citations:
PubMed Identifier
31802967
Citation
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.
Results Reference
derived
PubMed Identifier
30521533
Citation
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.
Results Reference
derived
PubMed Identifier
30206821
Citation
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.
Results Reference
derived
PubMed Identifier
30084288
Citation
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.
Results Reference
derived
PubMed Identifier
27611736
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081030&StudyName=A+Study+To+Evaluate+The+Safety+And+Efficacy+Of+Pregabalin+In+Patients+With+Painful+Diabetic+Peripheral+Neuropathy+%28DPN%29%2E
Description
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A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

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