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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
pregabalin
pregabalin
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.
Patient Global Impression of Change (PGIC)
Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).

Secondary Outcome Measures

Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.
Change From Baseline in Weekly Mean Sleep Quality Score
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.
Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14
MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14
Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.
Total Daily Acetaminophen Dose
Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).

Full Information

First Posted
June 2, 2006
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00333866
Brief Title
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
600mg/day
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
450mg/day
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
300mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
Description
Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.
Time Frame
Baseline, Week 14
Title
Patient Global Impression of Change (PGIC)
Description
Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)
Description
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Weekly Mean Sleep Quality Score
Description
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Title
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Description
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14
Description
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14
Description
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14
Description
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14
Description
MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).
Time Frame
Baseline, Week 14
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14
Description
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14
Description
Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.
Time Frame
Baseline, Week 14
Title
Total Daily Acetaminophen Dose
Description
Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).
Time Frame
Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Warrawong
State/Province
New South Wales
ZIP/Postal Code
2502
Country
Australia
Facility Name
Pfizer Investigational Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Pfizer Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Pfizer Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3K 2A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Montpellier
State/Province
Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Pfizer Investigational Site
City
Bad Saeckingen
ZIP/Postal Code
79713
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 001
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 008
Country
India
Facility Name
Pfizer Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 014
Country
India
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
79124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
Country
Italy
Facility Name
Pfizer Investigational Site
City
Suwon-si
State/Province
Kyeongki-do
ZIP/Postal Code
442-712
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
143-914
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
D. F.
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37520
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1050-054
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1249-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisbon
ZIP/Postal Code
1700-360
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Pfizer Investigational Site
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
ZIP/Postal Code
431 37
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
SE-112 81
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenock
State/Province
Renfrewshire
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
North Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
WC1X 8LD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Poole
ZIP/Postal Code
BH12 2JB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Distrito Capital
ZIP/Postal Code
1010
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Distrito Capital
ZIP/Postal Code
1060
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Estado Miranda
ZIP/Postal Code
1081
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
26694975
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.
Results Reference
derived
PubMed Identifier
21965636
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.
Results Reference
derived
PubMed Identifier
21639874
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.
Results Reference
derived
PubMed Identifier
21039311
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.
Results Reference
derived
PubMed Identifier
20584327
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081100&StudyName=Randomized%2C%20Double-Blind%2C%20Placebo-Controlled%20Trial%20Of%20Pregabalin%20%20In%20Patients%20With%20Fibromyalgia.
Description
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Learn more about this trial

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

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