A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

NCT ID: NCT01432236

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pregabalin

Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose

Placebo

Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo capsules twice a day for 14 weeks

Interventions

Pregabalin

Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose

Intervention Type: DRUG

placebo

placebo capsules twice a day for 14 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Genova Clinical Research

Tucson, Arizona, United States

SDS Clinical Trials

Orange, California, United States

Research Across America

Santa Ana, California, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Florida Medical Center & Research, Inc.

Coral Gables, Florida, United States

Meridien Research

Tampa, Florida, United States

Medical Research and Health Education Foundation, Inc.

Columbus, Georgia, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Social Psychiatry Research Institute

Brooklyn, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Radiant Research, Inc.

Columbus, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Sunstone Medical Research, LLC

Medford, Oregon, United States

Behavioral Medicine Center

Wyomissing, Pennsylvania, United States

Clinical Research Center of Reading, LLP

Wyomissing, Pennsylvania, United States

Coastal Medical

East Greenwich, Rhode Island, United States

Omega Medical Research

Warwick, Rhode Island, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Fatigue Consultation Clinic

Salt Lake City, Utah, United States

Lifetree Clinical Research, LC

Salt Lake City, Utah, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, Canada

Canadian Centre for Clinical Trials

Thornhill, Ontario, Canada

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Azienda Ospedaliera Luigi Sacco - Polo Universitario

Milan, , Italy

Università degli Studi di Roma "La Sapienza"

Roma, , Italy

Hospital de lˊEsperança

Barcelona, , Spain

Instituto Universitario USP Dexeus

Barcelona, , Spain

Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital General Universitario de Guadalajara

Guadalajara, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Countries

United States; Canada; Italy; Spain

References

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.

Reference Type: DERIVED

PMID: 27057659 (View on PubMed)

Arnold 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.

Reference Type: DERIVED

PMID: 26034150 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081275&StudyName=A%20Phase%203b%20Multicenter%20Study%20of%20Pregabalin%20in%20Fibromyalgia%20Subjects%20Who%20Have%20Comorbid%20Depression

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Other Identifiers

2011-002480-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A0081275

Identifier Type: -

Identifier Source: org_study_id