Safety and Efficacy of Pregabalin in Patients With 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

NCT00141401

Enrollment

240

Registered

2005-09-01

Start date

1999-09-30

Completion date

2005-07-31

Last updated

2007-08-17

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 long-term efficacy and safety of pregabalin in patients with 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 preceding double-blind study * Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.

Exclusion criteria

* Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind 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