Phase 3
N=193
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01432236 ↗Enrolled (actual)
193
Serious AEs
1.1%
Results posted
Oct 2014
Primary outcome: Primary: Mean NRS Pain Score at End of Period. — 4.84; 5.45 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
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean NRS Pain Score at End of Period. |
4.84; 5.45 | 0.0001 sig |
| SECONDARY Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. |
63.83; 62.75; 4.58; 4.44; 7.78; 7.43 | — |
| SECONDARY FIQ Score at End of Period. |
43.78; 50.38; 3.35; 3.77; 4.69; 5.53 | <0.0001 sig |
| SECONDARY Patient Global Impression of Change (PGIC) at the End of Period 1. |
10.8; 4.3; 35.5; 25.8; 28.0; 40.9 | 0.0637 |
| SECONDARY Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. |
45.3; 27.7; 26.0; 15.8 | 0.0007 sig |
| SECONDARY Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period. |
6.15; 5.57 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period. |
33.38; 41.18 | 0.0018 sig |
| SECONDARY Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period. |
33.54; 39.33 | 0.0117 sig |
| SECONDARY Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period. |
422.98; 414.63 | 0.0511 |
| SECONDARY Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period. |
0.48; 0.61 | 0.1139 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) at Baseline. |
8.67; 7.97; 8.34; 7.73 | — |
| SECONDARY HADS at End of Period. |
6.01; 6.96; 6.17; 7.05 | <0.0001 sig |
| SECONDARY Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline. |
0.40; 0.37 | — |
| SECONDARY EQ-5D Score at End of Period. |
0.58; 0.56 | 0.3854 |
Summary
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
Eligibility Criteria
Inclusion Criteria
- Men or women of any race or ethnicity who are at least 18 years of age.
- Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.
Exclusion Criteria
- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
- Patients with severe or unstable depression are not eligible.
- Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
- Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
Data sourced from ClinicalTrials.gov (NCT01432236). 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.