Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Conditions

Diabetic Neuropathies

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.

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

* 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.

Design outcomes

Primary

Measure	Time frame
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.	—

Secondary

Measure	Time frame
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.	—

Countries

Puerto Rico, United States

Outcome results

None listed