A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
2 other identifiers
interventional
197
4 countries
37
Brief Summary
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2011
CompletedFirst Posted
Study publicly available on registry
September 12, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
October 22, 2014
CompletedJanuary 22, 2021
October 1, 2014
1.8 years
September 8, 2011
May 12, 2014
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean NRS Pain Score at End of Period.
The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.
End of each period, at Weeks 6 and 14
Secondary Outcomes (13)
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
Baseline
FIQ Score at End of Period.
End of each period, at Weeks 6 and 14
Patient Global Impression of Change (PGIC) at the End of Period 1.
End of Period 1 at Week 6
Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.
Visits 2, 6, and 12
Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.
End of each period, at Weeks 6 and 14
- +8 more secondary outcomes
Other Outcomes (8)
PGIC at the End of Period 2.
End of Period 2 at Week 14
Mean Patient Static Global Assessment (PSGA) Score at Baseline.
Baseline
Mean PSGA Score at End of Period.
End of each period, at Weeks 6 and 14
- +5 more other outcomes
Study Arms (2)
Pregabalin
EXPERIMENTALGroup 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
Placebo
PLACEBO COMPARATORGroup 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
Interventions
Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
Eligibility Criteria
You may qualify if:
- Men or women of any race or ethnicity who are at least 18 years of age.
- Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.
You may not qualify if:
- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
- Patients with severe or unstable depression are not eligible.
- Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
- Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Genova Clinical Research
Tucson, Arizona, 85704, United States
SDS Clinical Trials
Orange, California, 92868, United States
Research Across America
Santa Ana, California, 92705, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Florida Medical Center & Research, Inc.
Coral Gables, Florida, 33134, United States
Meridien Research
Tampa, Florida, 33606, United States
Medical Research and Health Education Foundation, Inc.
Columbus, Georgia, 31909, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Behavioral Medicine Center
Wyomissing, Pennsylvania, 19610, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Coastal Medical
East Greenwich, Rhode Island, 02818, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102, United States
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, V2A 4M4, Canada
Canadian Centre for Clinical Trials
Thornhill, Ontario, L4J 1W3, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Azienda Ospedaliera Luigi Sacco - Polo Universitario
Milan, 20157, Italy
Università degli Studi di Roma "La Sapienza"
Roma, 00161, Italy
Hospital de lˊEsperança
Barcelona, 08024, Spain
Instituto Universitario USP Dexeus
Barcelona, 08028, Spain
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
Barcelona, 08034, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital General Universitario de Guadalajara
Guadalajara, 19002, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28028, Spain
Related Publications (2)
Bateman L, Sarzi-Puttini P, Burbridge CL, Landen JW, Masters ET, Bhadra Brown P, Scavone JM, Emir B, Vissing RS, Clair AG, Pauer LR. Burden of illness in fibromyalgia patients with comorbid depression. Clin Exp Rheumatol. 2016 Mar-Apr;34(2 Suppl 96):S106-13. Epub 2016 Mar 10.
PMID: 27057659DERIVEDArnold LM, Sarzi-Puttini P, Arsenault P, Khan T, Bhadra Brown P, Clair A, Scavone JM, Driscoll J, Landen J, Pauer L. Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study. J Rheumatol. 2015 Jul;42(7):1237-44. doi: 10.3899/jrheum.141196. Epub 2015 Jun 1.
PMID: 26034150DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2011
First Posted
September 12, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
January 22, 2021
Results First Posted
October 22, 2014
Record last verified: 2014-10