This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00346034|
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : March 13, 2009
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Pregabalin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||357 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
150 to 600mg/day
- Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 4 ]Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
- Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 12 (end of treatment) ]Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346034
|Study Director:||Pfizer CT.gov Call Center||Pfizer|