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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00333866




Registration number
NCT00333866
Ethics application status
Date submitted
2/06/2006
Date registered
6/06/2006
Date last updated
11/02/2021

Titles & IDs
Public title
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Scientific title
A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Secondary ID [1] 0 0
A0081100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pregabalin
Treatment: Drugs - pregabalin
Treatment: Drugs - pregabalin
Treatment: Drugs - placebo

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Placebo comparator: 4 -


Treatment: Drugs: pregabalin
600mg/day

Treatment: Drugs: pregabalin
450mg/day

Treatment: Drugs: pregabalin
300mg/day

Treatment: Drugs: placebo
placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
Timepoint [1] 0 0
Baseline, Week 14
Primary outcome [2] 0 0
Patient Global Impression of Change (PGIC)
Timepoint [2] 0 0
Week 14
Secondary outcome [1] 0 0
Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)
Timepoint [1] 0 0
Baseline, Week 14
Secondary outcome [2] 0 0
Change From Baseline in Weekly Mean Sleep Quality Score
Timepoint [2] 0 0
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary outcome [3] 0 0
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Timepoint [3] 0 0
Baseline, Week 14
Secondary outcome [4] 0 0
Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14
Timepoint [4] 0 0
Baseline, Week 14
Secondary outcome [5] 0 0
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14
Timepoint [5] 0 0
Baseline, Week 14
Secondary outcome [6] 0 0
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14
Timepoint [6] 0 0
Baseline, Week 14
Secondary outcome [7] 0 0
Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14
Timepoint [7] 0 0
Baseline, Week 14
Secondary outcome [8] 0 0
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14
Timepoint [8] 0 0
Baseline, Week 14
Secondary outcome [9] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14
Timepoint [9] 0 0
Baseline, Week 14
Secondary outcome [10] 0 0
Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14
Timepoint [10] 0 0
Baseline, Week 14
Secondary outcome [11] 0 0
Total Daily Acetaminophen Dose
Timepoint [11] 0 0
Week 14

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
747
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Warrawong
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2502 - Warrawong
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Denmark
State/province [7] 0 0
Frederiksberg
Country [8] 0 0
Denmark
State/province [8] 0 0
Svendborg
Country [9] 0 0
France
State/province [9] 0 0
Cedex 5
Country [10] 0 0
France
State/province [10] 0 0
Cedex
Country [11] 0 0
France
State/province [11] 0 0
Clermont Ferrand Cedex 1
Country [12] 0 0
France
State/province [12] 0 0
Paris Cedex 04
Country [13] 0 0
France
State/province [13] 0 0
Saint Etienne Cedex 2
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Saeckingen
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Bonn
Country [17] 0 0
Germany
State/province [17] 0 0
Mannheim
Country [18] 0 0
Germany
State/province [18] 0 0
Muenchen
Country [19] 0 0
India
State/province [19] 0 0
Madhya Pradesh
Country [20] 0 0
India
State/province [20] 0 0
Punjab
Country [21] 0 0
India
State/province [21] 0 0
Uttar Pradesh
Country [22] 0 0
Italy
State/province [22] 0 0
Bari
Country [23] 0 0
Italy
State/province [23] 0 0
Benevento
Country [24] 0 0
Italy
State/province [24] 0 0
Bologna
Country [25] 0 0
Italy
State/province [25] 0 0
Chieti Scalo
Country [26] 0 0
Italy
State/province [26] 0 0
Perugia
Country [27] 0 0
Italy
State/province [27] 0 0
Pisa
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Kyeongki-do
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Mexico
State/province [30] 0 0
D. F.
Country [31] 0 0
Mexico
State/province [31] 0 0
Guanajuato
Country [32] 0 0
Mexico
State/province [32] 0 0
Nuevo Leon
Country [33] 0 0
Mexico
State/province [33] 0 0
San Luis Potosi
Country [34] 0 0
Netherlands
State/province [34] 0 0
Alkmaar
Country [35] 0 0
Netherlands
State/province [35] 0 0
Den Helder
Country [36] 0 0
Netherlands
State/province [36] 0 0
Leeuwarden
Country [37] 0 0
Netherlands
State/province [37] 0 0
Rotterdam
Country [38] 0 0
Netherlands
State/province [38] 0 0
Zwolle
Country [39] 0 0
Portugal
State/province [39] 0 0
Lisboa
Country [40] 0 0
Portugal
State/province [40] 0 0
Lisbon
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Cordoba
Country [43] 0 0
Spain
State/province [43] 0 0
Guadalajara
Country [44] 0 0
Sweden
State/province [44] 0 0
Linkoping
Country [45] 0 0
Sweden
State/province [45] 0 0
Molndal
Country [46] 0 0
Sweden
State/province [46] 0 0
Orebro
Country [47] 0 0
Sweden
State/province [47] 0 0
Stockholm
Country [48] 0 0
Switzerland
State/province [48] 0 0
Lausanne
Country [49] 0 0
Switzerland
State/province [49] 0 0
Zurich
Country [50] 0 0
Switzerland
State/province [50] 0 0
Zürich
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Greater Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Renfrewshire
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Tyne And Wear
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Poole
Country [56] 0 0
Venezuela
State/province [56] 0 0
Distrito Capital
Country [57] 0 0
Venezuela
State/province [57] 0 0
Estado Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00333866
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00333866