Phase 3
N=343
A Study For Pregabalin In Patients With Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01387607 ↗Enrolled (actual)
343
Serious AEs
2.7%
Results posted
Jul 2018
Primary outcome: Primary: Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 — -2.01; -1.28 Units on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 |
-2.01; -1.28 | 0.0001 sig |
| SECONDARY Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 |
9.9; 7.7; 25.4; 19.7; 40.1; 42.3 | 0.1397 |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 |
-11.14; -8.15 | 0.0762 |
| SECONDARY Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 |
47.5; 32.7 | 0.0044 sig |
| SECONDARY Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 |
27.2; 17.0 | 0.0189 sig |
| SECONDARY Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score |
-11.45; -8.02 | 0.0900 |
| SECONDARY Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores |
4.61; 2.08; -6.76; -4.41; 14.23; 5.20 | 0.2485 |
| SECONDARY Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores |
0.61; 0.32; -1.29; -5.48 | 0.0106 sig |
| SECONDARY Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score |
-9.70; -6.64 | 0.0637 |
| SECONDARY Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale |
41.2; 43.6 | 0.6767 |
| SECONDARY Change From Baseline in Mean Sleep Interference Score at Week 14 |
-1.88; -1.00 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) |
-42.36; -25.19 | 0.0273 sig |
| SECONDARY Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) |
-0.26; -0.28 | 0.8082 |
| SECONDARY Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) |
-0.95; -0.30 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) |
24.63; 17.23 | 0.3388 |
| SECONDARY Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality |
1.59; 0.82 | 0.0003 sig |
| SECONDARY Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 |
-4.09; -3.25 | 0.3186 |
| SECONDARY Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score |
2.68; 2.30 | 0.7149 |
| SECONDARY Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score |
4.44; 3.66 | 0.2442 |
| SECONDARY Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 |
-17.04; -13.43 | 0.1332 |
| SECONDARY Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score |
-1.03; -0.65 | 0.2934 |
| SECONDARY Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score |
-1.11; -0.28 | 0.0226 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs |
119; 103; 0; 9; 22; 11 | — |
| SECONDARY Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity |
183; 162; 52; 30; 38; 25 | — |
Summary
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Eligibility Criteria
Inclusion Criteria
- Male or female patients, at least 18 years of age
- Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
- At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
- At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
Exclusion Criteria
- Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
- Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
- Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
- CLcr less than 60 mL/min (estimated from serum creatinine)
Data sourced from ClinicalTrials.gov (NCT01387607). 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.