To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150423

Enrollment

384

Registered

2005-09-08

Start date

2001-01-31

Completion date

2005-07-31

Last updated

2007-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy, Painful

Brief summary

To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.

Interventions

DRUGPregabalin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy * Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion criteria

* Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.

Design outcomes

Primary

Measure	Time frame
Safety Efficacy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026