Fibromyalgia
Conditions
Brief summary
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
Interventions
DRUGPregabalin Release Tablets
DRUGPlacebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites). Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .
Exclusion criteria
* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia. Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean pain score diary at Endpoint | Baseline and 15 weeks | derived from the subject's daily pain |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in SF-36 scores at Weeks 15 | Baseline and Weeks 15 |
| Change from baseline in HADS scores at Weeks 15 | Baseline and Weeks 15 |
| Change from baseline in FIQ scores at Weeks 15 | Baseline and Weeks 15 |
| Quality of Sleep Score from the Daily Sleep Diary | up to 15 weeks |
| Mean pain score from the subject's daily pain | up to 15 weeks |
| Change from baseline in MOS-SS scores at Weeks 15 | Baseline and Weeks 15 |
Countries
China
Outcome results
None listed