| January 29, 2008 |
| July 9, 2009 |
| December 2007 |
| May 2009 (final data collection date for primary outcome measure) |
- Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00612170 on ClinicalTrials.gov Archive Site |
- Change from baseline in the endpoint mean sleep interference score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Multidimensional Assessment of Fatigue [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Short Form 36 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Sheehan Disability Score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Pain Visual Analogue Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
|
- Change from baseline in the endpoint mean sleep intereference score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Fibromylagia Impact Questionnaire [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Short Form 36 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Sheehan Disability Score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Pain Visual Analogue Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
|
| |
| A 14-Week, Multi-Center Study of [S,S]-Reboxetine in Patients With Fibromyalgia. |
| A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia |
This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Fibromyalgia |
- Drug: [S,S]-Reboxetine
- Drug: Placebo
|
| |
| |
| |
| Completed |
| 1129 |
| May 2009 |
| May 2009 (final data collection date for primary outcome measure) |
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)
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00612170 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A6061043, A6061043 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| July 2009 |
