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

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150423

Purpose

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

Condition	Intervention	Phase
Diabetic Neuropathy, Painful	Drug: Pregabalin	Phase III

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Estimated Enrollment:	384
Study Start Date:	January 2001
Estimated Study Completion Date:	July 2005

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150423

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	1008-165
Study First Received:	September 6, 2005
Last Updated:	December 28, 2006
ClinicalTrials.gov Identifier:	NCT00150423
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin

Neurologic Manifestations
Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009