A Safety Study Of Pregabalin In Fibromyalgia

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00282997

First received: January 26, 2006

Last updated: March 21, 2008

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2006

Last Updated Date

March 21, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To evaluate the safety of pregabalin in patients with fibromyalgia

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00282997 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 Safety Study Of Pregabalin In Fibromyalgia

Official Title ^ICMJE

A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Brief Summary

To evaluate the safety of pregabalin in patients with fibromyalgia.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Drug: pregabalin

Study Arm (s)

Not Provided

Publications *

Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. Epub 2012 Apr 14.

* 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

500

Completion Date

October 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
Patients must complete the double-blind study.

Exclusion Criteria:

Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

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

United States

Administrative Information

NCT Number ^ICMJE

NCT00282997

Other Study ID Numbers ^ICMJE

A0081078

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2007

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

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