Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141401

Purpose

To evaluate long-term efficacy and safety of pregabalin in patients with 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:

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141401

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:	1008-074
Study First Received:	August 30, 2005
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00141401
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin

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 13, 2009