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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00156078

First received: September 7, 2005

Last updated: March 28, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

March 28, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Mean pain score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00156078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Neuropathy, Painful

Intervention ^ICMJE

Drug: pregabalin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

May 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Brazil, Chile, Colombia, Ecuador, Indonesia, Jordan, Korea, Republic of, Lebanon, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela

Administrative Information

NCT Number ^ICMJE

NCT00156078

Other Study ID Numbers ^ICMJE

A0081030

Has Data Monitoring Committee

Not Provided

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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