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

A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: placebo; Drug: pregabalin; Drug: pregabalin; Drug: pregabalin

• Study Type: Interventional
• Enrollment (Actual): 747
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Warrawong, New South Wales, Australia, 2502
      • Pfizer Investigational Site
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Pfizer Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Pfizer Investigational Site
    • Fitzroy, Victoria, Australia, 3065
      • Pfizer Investigational Site
• Canada
  • Quebec, Canada, G1V 3M7
    • Pfizer Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3E1
      • Pfizer Investigational Site
  • Ontario
    • Hawkesbury, Ontario, Canada, K6A 1A1
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M3K 2A7
      • Pfizer Investigational Site
  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3T 1E2
      • Pfizer Investigational Site
    • Pointe Claire, Quebec, Canada, H9R 3J1
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Pfizer Investigational Site
• Denmark
  • Frederiksberg, Denmark, 2000
    • Pfizer Investigational Site
  • Svendborg, Denmark, 5700
    • Pfizer Investigational Site
• France
  • Clermont Ferrand Cedex 1, France, 63003
    • Pfizer Investigational Site
  • Paris Cedex 04, France, 75181
    • Pfizer Investigational Site
  • Saint Etienne Cedex 2, France, 42055
    • Pfizer Investigational Site
  • Cedex
    • Lille, Cedex, France, 59037
      • Pfizer Investigational Site
  • Cedex 5
    • Montpellier, Cedex 5, France, 34295
      • Pfizer Investigational Site
• Germany
  • Bad Saeckingen, Germany, 79713
    • Pfizer Investigational Site
  • Berlin, Germany, 10117
    • Pfizer Investigational Site
  • Berlin, Germany, 14109
    • Pfizer Investigational Site
  • Bonn, Germany, 53105
    • Pfizer Investigational Site
  • Mannheim, Germany, 68161
    • Pfizer Investigational Site
  • Muenchen, Germany, 80336
    • Pfizer Investigational Site
• India
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452001
      • Pfizer Investigational Site
  • Punjab
    • Ludhiana, Punjab, India, 141 001
      • Pfizer Investigational Site
    • Ludhiana, Punjab, India, 141 008
      • Pfizer Investigational Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 014
      • Pfizer Investigational Site
• Italy
  • Bari, Italy, 79124
    • Pfizer Investigational Site
  • Benevento, Italy, 82100
    • Pfizer Investigational Site
  • Bologna, Italy, 40138
    • Pfizer Investigational Site
  • Chieti Scalo, Italy, 66013
    • Pfizer Investigational Site
  • Perugia, Italy, 06100
    • Pfizer Investigational Site
  • Pisa, Italy
    • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 143-914
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 133-792
    • Pfizer Investigational Site
  • Kyeongki-do
    • Suwon-si, Kyeongki-do, Korea, Republic of, 442-712
      • Pfizer Investigational Site
• Mexico
  • San Luis Potosi, Mexico, 78240
    • Pfizer Investigational Site
  • D. F.
    • Mexico, D. F., Mexico, 14080
      • Pfizer Investigational Site
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37520
      • Pfizer Investigational Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64020
      • Pfizer Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Pfizer Investigational Site
  • Den Helder, Netherlands, 1782 GZ
    • Pfizer Investigational Site
  • Leeuwarden, Netherlands, 8934 AD
    • Pfizer Investigational Site
  • Rotterdam, Netherlands, 3015 GD
    • Pfizer Investigational Site
  • Zwolle, Netherlands, 8011 JW
    • Pfizer Investigational Site
• Portugal
  • Lisboa, Portugal, 1349-019
    • Pfizer Investigational Site
  • Lisboa, Portugal, 1050-054
    • Pfizer Investigational Site
  • Lisboa, Portugal, 1249-075
    • Pfizer Investigational Site
  • Lisbon, Portugal, 1700-360
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Barcelona, Spain, 08024
    • Pfizer Investigational Site
  • Cordoba, Spain, 14004
    • Pfizer Investigational Site
  • Guadalajara, Spain, 19002
    • Pfizer Investigational Site
• Sweden
  • Linkoping, Sweden, 581 85
    • Pfizer Investigational Site
  • Molndal, Sweden, 431 37
    • Pfizer Investigational Site
  • Orebro, Sweden, 701 85
    • Pfizer Investigational Site
  • Stockholm, Sweden, SE-112 81
    • Pfizer Investigational Site
• Switzerland
  • Lausanne, Switzerland, 1011
    • Pfizer Investigational Site
  • Zurich, Switzerland, 8091
    • Pfizer Investigational Site
  • Zürich, Switzerland, 8063
    • Pfizer Investigational Site
• United Kingdom
  • London, United Kingdom, WC1X 8LD
    • Pfizer Investigational Site
  • Poole, United Kingdom, BH12 2JB
    • Pfizer Investigational Site
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M6 8HD
      • Pfizer Investigational Site
  • Renfrewshire
    • Greenock, Renfrewshire, United Kingdom, PA16 0XN
      • Pfizer Investigational Site
  • Tyne And Wear
    • North Shields, Tyne And Wear, United Kingdom, NE29 8NH
      • Pfizer Investigational Site
• Venezuela
  • Distrito Capital
    • Caracas, Distrito Capital, Venezuela, 1010
      • Pfizer Investigational Site
    • Caracas, Distrito Capital, Venezuela, 1060
      • Pfizer Investigational Site
  • Estado Miranda
    • Caracas, Estado Miranda, Venezuela, 1081
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: pregabalin; 600mg/day; Drug: pregabalin; 450mg/day; Drug: pregabalin; 300mg/day
EXPERIMENTAL: 2	Drug: pregabalin; 600mg/day; Drug: pregabalin; 450mg/day; Drug: pregabalin; 300mg/day
EXPERIMENTAL: 3	Drug: pregabalin; 600mg/day; Drug: pregabalin; 450mg/day; Drug: pregabalin; 300mg/day
PLACEBO_COMPARATOR: 4	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 14
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).	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 14
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.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
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.	Baseline, Week 14
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.	Baseline, Week 14
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.	Baseline, Week 14
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.	Baseline, Week 14
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.	Baseline, Week 14
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).	Baseline, Week 14
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.	Baseline, Week 14
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.	Baseline, Week 14
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).	Week 14

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: June 2, 2006
• First Submitted That Met QC Criteria: June 2, 2006
• First Posted (ESTIMATE): June 6, 2006

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081100