Phase 3
Completed N=498
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Source: ClinicalTrials.gov NCT00830167 ↗Enrolled (actual)
498
Serious AEs
0.2%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline — -1.03; -1.48 Scores on a scale — p=0.0046
Summary
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline |
-1.03; -1.48 | 0.0046 sig |
| SECONDARY Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC) |
62.1; 70.0 | 0.0078 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance |
-8.13; -17.62 | <0.0001 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring |
-1.61; 3.37 | 0.9958 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache |
-3.02; -8.01 | 0.0049 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep |
0.17; 0.46 | 0.0007 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy |
8.02; 15.50 | <0.0001 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence |
-4.66; 6.65 | 1.0000 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index |
-7.07; -10.06 | 0.0137 sig |
| SECONDARY Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint |
53; 71 | 0.0687 |
| SECONDARY Change From Baseline in Sleep Quality Score at Endpoint |
-0.79; -1.52 | <0.0001 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores |
-7.26; -10.59 | 0.0144 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function |
-0.19; -0.47 | 0.0376 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good |
-0.82; -1.45 | 0.0052 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss |
-0.30; -0.31 | 0.4768 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework |
-1.00; -1.32 | 0.0729 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain |
-1.06; -1.46 | 0.0238 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness |
-0.94; -1.43 | 0.0075 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning |
-0.97; -1.56 | 0.0023 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness |
-0.90; -1.05 | 0.2568 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious |
-0.64; -0.92 | 0.1011 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression |
-0.51; -0.55 | 0.4165 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning |
4.72; 9.01 | 0.0006 sig |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical |
8.36; 10.04 | 0.1805 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain |
9.50; 11.65 | 0.0770 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception |
2.83; 4.66 | 0.0648 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning |
6.84; 8.43 | 0.2068 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional |
3.50; 3.27 | 0.5480 |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality |
5.12; 9.53 | 0.0052 sig |
| SECONDARY Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health |
3.33; 5.97 | 0.0287 sig |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety |
-0.09; -0.57 | 0.0262 sig |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression |
0.00; -0.29 | 0.1561 |
| SECONDARY Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint |
-14.11; -20.30 | 0.0013 sig |
Eligibility Criteria
Inclusion Criteria
- ACR criteria for fibromyalgia
- A score of more or equal to 40 mm on the Pain VAS
- An average score more or equal to 4 on 4 daily pain diaries
Exclusion Criteria
- Patients with other severe pain conditions
- Patients with severe depression
- Patients taking excluded medications
- Patients with suicidality
Data sourced from ClinicalTrials.gov (NCT00830167). 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.