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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00333866