A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN) - Full Text View

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

This study has been completed.

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

MedlinePlus related topics:

Diabetic Nerve Problems Peripheral Nerve Disorders

ChemIDplus related topics:

Pregabalin

U.S. FDA Resources

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).

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

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

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

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 October 10, 2008