Phase 3
Completed N=106
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Source: ClinicalTrials.gov NCT00830128 ↗Enrolled (actual)
106
Serious AEs
2.8%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 102; 3 Participants
Summary
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
102; 3 | — |
| SECONDARY Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint |
-13.1 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint |
-9.6 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint |
1.9 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint |
-3.0 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint |
4.2 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint |
0.3 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint |
7.2 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint |
-3.7 | — |
| SECONDARY Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint |
26; 80 | — |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint |
-4.9 | — |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint |
-0.2; -0.4; -0.5; -0.7; -1.0; -0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, 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 A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
Data sourced from ClinicalTrials.gov (NCT00830128). 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.