Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Conditions

Diabetic Neuropathy, Painful

Brief summary

The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.

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

* Adults with Type 1 or 2 diabetes * Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion criteria

* Patients must not be in poor or unstable health.

Design outcomes

Primary

Measure	Time frame
Nerve conduction measurements; Pain scores from patient diaries	—

Secondary

Measure	Time frame
Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change	—

Countries

United States

Outcome results

None listed