Clinical trial NCT01271933: Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Official title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: fibromyalgia
pain
pregabalin
Lyrica
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 441
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: The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.


Eligibility criteria: Inclusion Criteria:

* Patients must have fibromyalgia.

Exclusion Criteria:

* Patients with other painful conditions cannot participate.

Primary outcomes:
measure: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)
timeFrame: Randomization to Week 19
measure: Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
timeFrame: Randomization to Week 19
Secondary outcomes:
measure: Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
timeFrame: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit
timeFrame: Baseline, Double blind endpoint visit (Week 19)
measure: Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)
timeFrame: Baseline, Week 19
measure: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II
timeFrame: Baseline, Week 6
measure: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II
timeFrame: Baseline, Week 19
measure: Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep
timeFrame: Baseline, Week 19
measure: Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6
timeFrame: Week 6
measure: Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19
timeFrame: Week 19
measure: Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19
timeFrame: Baseline, Week 19
measure: Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in HADS Score at Week 19
timeFrame: Baseline, Week 19
measure: Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in FIQ Score at Week 19
timeFrame: Baseline, Week 19
measure: Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline in MFI Score at Week 19
timeFrame: Baseline, Week 19
measure: Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6
timeFrame: Week 6
measure: Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19
timeFrame: Week 19
measure: Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6
timeFrame: Baseline, Week 6
measure: Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19
timeFrame: Baseline, Week 19
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)
timeFrame: Baseline, Double blind end point visit (Week 19)
Other outcomes:
measure: Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7
timeFrame: Baseline, Weeks 3, 4, 5, 6 and 7
measure: Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7
timeFrame: Baseline, Weeks 3, 4, 5, 6 and 7
measure: Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7
timeFrame: Baseline, Weeks 3, 4, 5, 6 and 7
measure: Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7
timeFrame: Baseline, Weeks 3, 4, 5, 6 and 7
measure: Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7
timeFrame: Baseline, Weeks 3, 4, 5, 6 and 7
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15
timeFrame: Baseline, Weeks 11, 12, 13, 14 and 15
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15
timeFrame: Baseline, Weeks 11, 12, 13, 14 and 15
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15
timeFrame: Baseline, Weeks 11, 12, 13, 14 and 15
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15
timeFrame: Baseline, Weeks 11, 12, 13, 14 and 15
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15
timeFrame: Baseline, Weeks 11, 12, 13, 14 and 15
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)
timeFrame: Baseline, Double blind end point visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)
timeFrame: Baseline, Double blind end point visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)
timeFrame: Baseline, Double blind end point visit (Week 19)
measure: Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)
timeFrame: Baseline, Double blind end point visit (Week 19)
measure: Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)
timeFrame: Week 1 to Week 7 and Week 11 to Week 20
Locations:
city: Orange
country: United States
facility: Andrew O. Schreiber, MD
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Ocala
country: United States
facility: Paddock Park Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Moline
country: United States
facility: Arthritis Care Center
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic, Inc
state: Indiana
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Incorporated
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Minot
country: United States
facility: Trinity Health Organization
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Radiant Research,
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Bethlehem
country: United States
facility: East Penn RheumatologyAssociates, P.C.
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Fatigue Consultation Clinic
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Tacoma
country: United States
facility: Tacoma Center for Arthritis Research, PS
state: Washington
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Rivergrove Medical Clinic
state: Manitoba
city: Bathurst
country: Canada
facility: Maritime Research Center
state: New Brunswick
city: Bathurst
country: Canada
facility: Clinique Medicale Nepisiguit
state: New Brunswick
city: Mississauga
country: Canada
facility: Tri-Hospital Sleep Laboratory West
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Sleep & Alertness Research Inc.
state: Ontario
city: Pointe Claire
country: Canada
facility: West Island Rheumatology Research Associates
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Groupe de Recherche en Rhumatologie et Maladie Osseuses (GRMO Inc.)
city: Hyderabad
country: India
facility: Mahavir Hospital & Research Centre
state: Andhra Pradesh
city: Bangalore
country: India
facility: Chanre Rheumatology & Immunology Center & Research
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research & Development Center,
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Ludhiana
country: India
facility: Punjab Rheumatology Centre
state: Punjab
city: Lucknow
country: India
facility: Department of Rheumatology
state: Uttar Pradesh
city: New Delhi
country: India
facility: Indian Spinal Injuries Centre
city: Kwei Shan Town
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
state: Taoyuan County
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Arnold LM, Arsenault P, Huffman C, Patrick JL, Messig M, Chew ML, Sanin L, Scavone JM, Pauer L, Clair AG. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014 Oct;30(10):2069-83. doi: 10.1185/03007995.2014.928275. Epub 2014 Jun 27.