Clinical trial NCT00156078: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Mean pain score
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Niteroi
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Valparaiso
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogotá
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: Jakarta Pusat
country: Indonesia
facility: Pfizer Investigational Site
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Mexico Df
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Espana
country: Philippines
facility: Pfizer Investigational Site
state: Manila
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Gueishan Shiang
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyan Hsien
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Khet Rajathevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang MAI
city: Capa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Mersin
country: Turkey
facility: Pfizer Investigational Site
city: Abu Dhabi
country: United Arab Emirates
facility: Pfizer Investigational Site
city: El Hatillo
country: Venezuela
facility: Pfizer Investigational Site
state: Caracas-Estado Miranda
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.