An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00151528

First received: September 7, 2005

Last updated: March 7, 2008

Last verified: July 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

March 7, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00151528 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

There are no secondary outcome measures [ Designated as safety issue: No ]

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

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Official Title ^ICMJE

A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Brief Summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

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

428

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

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

NCT00151528

Other Study ID Numbers ^ICMJE

A0081057

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

July 2006

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

To Top