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...
Date First Received: November 23, 2009
Last Updated: January 12, 2010
Verified by: Pfizer, January 2010
Clinical Trial Phase: Phase 4 | Start Date: July 2010
Overall Status: Not yet recruiting
Estimated Enrollment: 162
Brief Summary
Official Title: “A 6-Month, Open-Label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia”
Condition Keyword(s):
Intervention(s):
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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Study Primary Completion Date: July 2013
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
- Time Frame: 6 month
Secondary Measures
- No secondary endpoints
- Time Frame: No secondary endpoints
Safety Issue?: No
- Time Frame: No secondary endpoints
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 Sponsor Information
Lead Sponsor: Pfizer
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 04, 2010
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
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