Phase 3
Completed N=747
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Source: ClinicalTrials.gov NCT00333866 ↗Enrolled (actual)
747
Serious AEs
2.5%
Results posted
May 2009
Primary outcomePrimary: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) — -0.73; -1.06; -1.29; -0.96 Units on a scale — p=0.2361
Summary
This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) |
-0.73; -1.06; -1.29; -0.96 | 0.2361 |
| PRIMARY Patient Global Impression of Change (PGIC) |
7; 13; 16; 20; 43; 45 | 0.0227 sig |
| SECONDARY Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) |
-0.94; -1.42; -1.72; -1.95 | <.0001 sig |
| SECONDARY Change From Baseline in Weekly Mean Sleep Quality Score |
-0.38; -1.20; -1.08; -1.23; -0.62; -1.48 | <.0001 sig |
| SECONDARY Percentage of Participants With Optimal Sleep Assessed Using MOS-SS |
30.8; 33.5; 44.0; 32.4 | 0.5370 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 |
-5.99; -13.18; -19.26; -18.70; -0.03; 1.17 | <.0001 sig |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 |
-0.09; -0.26; -0.35; -0.26; -1.15; -1.11 | 0.3627 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 |
-6.94; -8.11; -12.79; -8.38 | 0.4200 |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 |
4.64; 5.22; 6.63; 4.13; 4.01; 4.40 | 0.7781 |
| SECONDARY Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 |
-1.91; -2.78; -3.32; -2.19 | 0.7384 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 |
-0.31; -0.42; -0.81; -0.90; -0.11; -0.33 | 0.0900 |
| SECONDARY Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 |
-10.30; -12.86; -17.75; -11.74 | 0.5340 |
| SECONDARY Total Daily Acetaminophen Dose |
460.65; 449.14; 508.53; 724.42 | 0.1277 |
Eligibility Criteria
Inclusion Criteria
- ACR criteria for fibromyalgia
- A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a 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
Data sourced from ClinicalTrials.gov (NCT00333866). 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.