Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

April 9, 2008

Start Date ^†

March 2005

Current Primary Outcome Measures ^†

The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00143156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Brief Summary

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Neuropathies

Intervention ^†

Drug: pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

450

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Males or females at least 18 years of age, of any ethnic origin
Type 1 or 2 diabetes mellitus
Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Puerto Rico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143156

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.