Phase 3 N=498 Randomized Triple-blind Treatment

Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00830167 ↗

Enrolled (actual)

498

Serious AEs

0.2%

Results posted

Jun 2012

Primary outcome: 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 Scores on a scale — p=0.0046

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: May 2011

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

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.

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

View full record on ClinicalTrials.gov →

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.