Fibromyalgia
Conditions
Keywords
Phase 3, safety study, [S,S]-Reboxetine, Fibromyalgia
Brief summary
This is a study to investigate the long-term safety and effectiveness \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
Interventions
DRUG[S,S]-Reboxetine
Once a day, oral treatment, of 4, 6, 8 or 10 mg
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female of any race, at least 18 years of age * Patients must meet the 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) * Completed preceding double-blind randomized, controlled trial
Exclusion criteria
* Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia * Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder * A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression * History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs | 66 weeks |
| 12-Lead ECG | 66 weeks |
| Hematology & Biochemistry Laboratory Parameters | 66 weeks |
| Adverse Events | 66 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Short-Form 36 Health Survey | 66 weeks |
| Fibromyalgia Impact Questionaire | 66 weeks |
| Sheehan Disability Scale | 66 weeks |
| Pain Visual Analogue Scale | 66 weeks |
| Multidimensional Assessment of Fatigue | 66 weeks |
Countries
Canada, United States
Outcome results
None listed