Phase 3
Completed N=441
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Source: ClinicalTrials.gov NCT01271933 ↗Enrolled (actual)
441
Serious AEs
1.3%
Results posted
Sep 2018
Primary outcomePrimary: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) — 58; 23 Days — p=0.0186
◆ Published Evidence
Established
26citations · ~2 / year
Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
Summary
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
Linked Publications
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Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) |
58; 23 | 0.0186 sig |
| PRIMARY Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event |
34; 41 | — |
| SECONDARY Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 |
-0.9; -1.5; -2.0; -2.3; -2.5; -2.6 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
-3.9; -3.0; -3.7; -2.7; -3.6; -2.8 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit |
-2.9; -2.5 | 0.3310 |
| SECONDARY Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 |
-0.7; -1.2; -1.6; -2.0; -2.2; -2.3 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
-3.4; -3.0; -3.3; -2.8; -3.2; -2.9 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit |
-2.6; -2.5 | 0.9247 |
| SECONDARY Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 |
-19.1; -22.4; -25.0; -27.5; -31.4; -32.8 | — |
| SECONDARY Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 |
-0.8; -1.0; -1.1; -1.1; -1.2; -1.2 | — |
| SECONDARY Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 |
0.6; 0.6; 0.6; 0.7; 0.7; 0.7 | — |
| SECONDARY Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 |
1.0; 1.2; 1.5; 1.6; 1.7; 1.7 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
-27.8; -32.0; -27.4; -28.0; -27.0; -33.2 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
-1.1; -1.0; -1.2; -0.8; -1.2; -1.1 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
0.7; 0.5; 0.9; 0.6; 0.8; 0.5 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
1.9; 1.9; 2.0; 1.7; 2.1; 1.8 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit |
-26.2; -20.6; -10.6; -11.9 | 0.4314 |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit |
-0.5; -0.8 | 0.4571 |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit |
0.6; 0.4 | 0.3779 |
| SECONDARY Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit |
1.9; 1.4 | 0.2009 |
| SECONDARY Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period) |
-1.6 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period) |
-3.1; -2.4 | 0.1845 |
| SECONDARY Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II |
-21.8; -1.0; -11.0; 18.9; -3.6; -16.1 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep |
0.7 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II |
-25.4; -15.5; -2.4; -2.9; -8.1; -4.2 | 0.0305 sig |
| SECONDARY Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep |
0.7; 0.5 | 0.3596 |
| SECONDARY Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 |
24; 77; 103; 46; 16; 18 | — |
| SECONDARY Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 |
7; 7; 15; 11; 14; 12 | 0.4985 |
| SECONDARY Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 |
14.0; 17.8; 20.7; 8.5; 18.2; 12.9 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 |
12.4; 13.7; 18.9; 16.2; 19.2; 16.0 | 0.7400 |
| SECONDARY Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6 |
-1.8; -1.5 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in HADS Score at Week 19 |
-0.7; -1.6; -1.4; -1.1 | 0.1901 |
| SECONDARY Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 |
-0.9; -2.2; -0.5; -1.5; -1.6; -1.4 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 |
-1.0; -1.3; -3.0; -3.2; -1.2; -1.0 | 0.3721 |
| SECONDARY Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 |
-0.2; 0.1; -0.2; 0.2; -0.1 | — |
| SECONDARY Double-Blind Phase: Change From Baseline in MFI Score at Week 19 |
0.1; -0.1; -0.1; 0.2; 0.0; -0.3 | 0.4606 |
| SECONDARY Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 |
69; 137; 211; 52; 59; 103 | — |
| SECONDARY Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 |
3; 11; 15; 16; 41; 30 | 0.0296 sig |
| SECONDARY Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 |
-5.8; -10.0; -13.5; -12.3 | — |
| SECONDARY Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 |
-7.3; -26.7; -14.0; -15.0; -16.4; -19.6 | 0.0562 |
| SECONDARY Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19) |
-182.7; -6672.2 | 0.6077 |
Eligibility Criteria
Inclusion Criteria
- Patients must have fibromyalgia.
Exclusion Criteria
- Patients with other painful conditions cannot participate.
Data sourced from ClinicalTrials.gov (NCT01271933) and the linked publication. 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.