Clinical trial NCT00333866: Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Official title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
timeFrame: Baseline, Week 14
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 14
Secondary outcomes:
measure: Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)
timeFrame: Baseline, Week 14
measure: Change From Baseline in Weekly Mean Sleep Quality Score
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
measure: Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
timeFrame: Baseline, Week 14
measure: Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14
timeFrame: Baseline, Week 14
measure: Total Daily Acetaminophen Dose
timeFrame: Week 14
Other outcomes:
Locations:
city: Warrawong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Fitzroy
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Saint John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Frederiksberg
country: Denmark
facility: Pfizer Investigational Site
city: Svendborg
country: Denmark
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 5
city: Lille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Clermont Ferrand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 04
country: France
facility: Pfizer Investigational Site
city: Saint Etienne Cedex 2
country: France
facility: Pfizer Investigational Site
city: Bad Saeckingen
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Benevento
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Chieti Scalo
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Suwon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyeongki-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D. F.
city: Leon
country: Mexico
facility: Pfizer Investigational Site
state: Guanajuato
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Den Helder
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisbon
country: Portugal
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Zürich
country: Switzerland
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater Manchester
city: Greenock
country: United Kingdom
facility: Pfizer Investigational Site
state: Renfrewshire
city: North Shields
country: United Kingdom
facility: Pfizer Investigational Site
state: Tyne And Wear
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Poole
country: United Kingdom
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Miranda
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
citation: Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, Leon T, Zeiher B; A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011 Dec;38(12):2643-52. doi: 10.3899/jrheum.110569. Epub 2011 Oct 1.
citation: Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
citation: Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.
citation: Bennett RM, Russell J, Cappelleri JC, Bushmakin AG, Zlateva G, Sadosky A. Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis. BMC Musculoskelet Disord. 2010 Jun 28;11:134. doi: 10.1186/1471-2474-11-134.