Clinical trial NCT00143156: Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Gatos
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Shrewsbury
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Frisco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Ponce
country: Puerto Rico
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.