Phase 3 N=747 Randomized Double-blind Treatment

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

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00333866 ↗

Enrolled (actual)

747

Serious AEs

2.5%

Results posted

May 2009

Primary outcome: Primary: 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

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: Nov 2007

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

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.

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

View full record on ClinicalTrials.gov →

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.