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OpenTrials
Completed

NCT Number: NCT00150423

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

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

Completed

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

Primary outcomes

  1. Safety Efficacy

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Jan 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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