A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

This study has been completed.

First Received: September 7, 2005 Last Updated: March 28, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00156078

Purpose

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

Condition	Intervention	Phase
Diabetic Neuropathy, Painful	Drug: pregabalin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean pain score

Estimated Enrollment:	450
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Type 1 or 2 diabetes mellitus.
Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion Criteria:

Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156078

Show 37 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081030
Study First Received:	September 7, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00156078 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:

Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pain
Signs and Symptoms
Neuromuscular Diseases

Peripheral Nervous System Diseases
Neurologic Manifestations
Endocrinopathy
Analgesics
Peripheral Nervous System Agents
Anticonvulsants
Diabetes Complications

Additional relevant MeSH terms:

Diabetic Neuropathies
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Neuromuscular Diseases

Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Diabetes Complications

ClinicalTrials.gov processed this record on September 11, 2009