Pain
Conditions
Brief summary
The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.
Interventions
DRUG[S,S]-Reboxetine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites). * At screening and randomization, patients must have a score of \>/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
Exclusion criteria
* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia. * Patients with severe hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly Average Pain Score from the Daily Pain Diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change | — |
| Short-Form 36 Health Survey (SF 36) | — |
| Sheehan Disability Scale | — |
| Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) | — |
| Quality of Sleep Score from the Daily Sleep Diary | — |
| Fibromyalgia Impact Questionnaire (FIQ) Total Score | — |
| Hospital Anxiety and Depression Scales (HADS) | — |
| Short-Form McGill Pain Questionnaire (SF-MPQ) | — |
| Fibromyalgia Health Assessment Questionnaire (F-HAQ) | — |
| Safety and Tolerability | — |
| Exposure Response Relationship Between Daily Dose and Daily Pain Score | — |
| Multidimensional Assessment of Fatigue (MAF) | — |
Countries
United States
Outcome results
None listed