Pregabalin In Adolescent Patients With Fibromyalgia

Verified by: Pfizer, January 2012
First Received: November 23, 2009 | Last Updated: January 18, 2012 | Phase: Phase 4 | Start Date: September 2010
Overall Status: Recruiting | Estimated Enrollment: 162
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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...

Brief Summary

Official Title: “A 6-Month, Open-Label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia”

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

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2014

Intervention(s) in this Clinical Trial

  • Drug: pregabalin
    • Oral capsule 75-450 mg/day

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Pregabalin

Outcome Measures for this Clinical Trial

Primary Measures

  • Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS)
    • Time Frame: 6 month
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01020526

Study ID Number: A0081231

ClinicalTrials.gov Identifier: NCT01020526

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01020526