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Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

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Viatris

Status and phase

Completed
Phase 4

Conditions

Diabetic Peripheral Neuropathy

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159731
A0081036

Details and patient eligibility

About

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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