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

Conditions

Diabetic Neuropathy, Painful

Brief summary

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

Joe Alexander, Roger Edwards, Luigi Manca, Roberto Grugni, Gianluca Bonfanti et al. (10 authors)

Pragmatic and Observational Research2019-10-018 citations

10.2147/por.s214412

Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy

Joe Alexander, Roger Edwards, Marina Brodsky, Luigi Manca, Roberto Grugni et al. (11 authors)

PLoS ONE2018-12-0613 citations

10.1371/journal.pone.0207120

Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment.

Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J.

2018-09-112 citations

10.1007/s12325-018-0780-3

The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus

Bruce Parsons, Chen-Tao Li, Birol Emir, Aaron I. Vinik

Current Medical Research and Opinion2018-08-076 citations

10.1080/03007995.2018.1509304

The efficacy of pregabalin in patients with moderate and severe pain due to diabetic peripheral neuropathy.

Parsons B, Li C.

2016-03-0815 citations

10.1185/03007995.2016.1151776

Interventions

DRUGpregabalin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Mean pain score	—

Countries

Argentina, Brazil, Chile, Colombia, Ecuador, Indonesia, Jordan, Lebanon, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, Venezuela

Outcome results

None listed