Pregabalin In Adolescent Patients With Fibromyalgia

This study is currently recruiting participants.

Verified April 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01020526

First received: November 23, 2009

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 23, 2009

Last Updated Date

April 29, 2013

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01020526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

There are no secondary endpoints [ Time Frame: There are no secondary endpoints ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pregabalin In Adolescent Patients With Fibromyalgia

Official Title ^ICMJE

A 6-Month, Open-Label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Brief Summary

The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

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

Oral capsule 75-450 mg/day

Study Arm (s)

Experimental: Pregabalin

Intervention: Drug: pregabalin

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

Recruiting

Estimated Enrollment ^ICMJE

162

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and 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 A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United States, Czech Republic, India

Administrative Information

NCT Number ^ICMJE

NCT01020526

Other Study ID Numbers ^ICMJE

A0081231

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2013

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

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