Phase 3
Completed N=357
This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
Source: ClinicalTrials.gov NCT00346034 ↗Enrolled (actual)
357
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score — -18.1 mm
Summary
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score |
-18.1 | — |
| PRIMARY Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score |
-20.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.
Exclusion Criteria
- Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.
Data sourced from ClinicalTrials.gov (NCT00346034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.