The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Xiehe Hospital of Beijing
Beijing, Beijing Municipality, China
RECRUITINGChange from baseline in mean pain score diary at Endpoint
derived from the subject's daily pain
Time frame: Baseline and 15 weeks
Change from baseline in FIQ scores at Weeks 15
Time frame: Baseline and Weeks 15
Change from baseline in SF-36 scores at Weeks 15
Time frame: Baseline and Weeks 15
Change from baseline in HADS scores at Weeks 15
Time frame: Baseline and Weeks 15
Change from baseline in MOS-SS scores at Weeks 15
Time frame: Baseline and Weeks 15
Quality of Sleep Score from the Daily Sleep Diary
Time frame: up to 15 weeks
Mean pain score from the subject's daily pain
Time frame: up to 15 weeks
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