Fibromyalgia Clinical Trial
Official title:
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Verified date | May 2016 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 63 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | Bioregeneracni a rehabilitacni centrum | Ricany | |
India | King George's Medical University | Lucknow | Uttar Pradesh |
India | Mallikatta Neuro Center | Mangalore | Karnataka |
India | Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics | Nagpur | Maharashtra |
India | Krishna Institute of Medical Sciences Ltd | Secunderabad | Andhra Pradesh |
United States | Akron Children's Hospital | Akron | Ohio |
United States | Akron Children's Hospital | Boardman | Ohio |
United States | Akron Children's Hospital-Mahoning Valley | Boardman | Ohio |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Medical University of South Carolina, Pediatric Rheumatology | Charleston | South Carolina |
United States | University of Cincinnati Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio |
United States | Medical Research & Health Education Foundation, Inc. | Columbus | Georgia |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | The Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | University of Louisville | Louisville | Kentucky |
United States | University Pediatric Rheumatology of Kentucky, LLC | Louisville | Kentucky |
United States | Florida Medical Center & Research | Miami | Florida |
United States | Carolina Research Center | Myrtle Beach | South Carolina |
United States | Harmony Clinical Research, Incorporated | North Miami Beach | Florida |
United States | Rheumatology Associates of Central Florida, PA | Orlando | Florida |
United States | Fatigue Consultation Clinic | Salt Lake City | Utah |
United States | Apex Research Institute | Santa Ana | California |
United States | University of Massachusetts Memorial Medical Center Department of Pediatrics | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Czechia, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Pain Numeric Rating Scale by Week | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. | Baseline, Weeks 3, 8, 16, 24 and Last Visit. |
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