Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

NCT01271933 | Completed Phase 3 Results

• 2 other identifiers: A0081245FIBROMYALGIA
• Study Type: interventional
• Target: 441
• Locations: 4 countries
• Sites: 52

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; pain; pregabalin; Lyrica

Outcome Measures

Primary Outcomes (2)

• Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)

  The time to loss of therapeutic response (LTR) is the time to loss of pain response (\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).

  Randomization to Week 19

• Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event

  Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.

  Randomization to Week 19

Secondary Outcomes (39)

• Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6

  Baseline, Weeks 1, 2, 3, 4, 5, 6

• 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

  Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

• Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit

  Baseline, Double blind endpoint visit (Week 19)

• Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6

  Baseline, Weeks 1, 2, 3, 4, 5, 6

• 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

  Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Other Outcomes (15)

• Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7

  Baseline, Weeks 3, 4, 5, 6 and 7

• Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7

  Baseline, Weeks 3, 4, 5, 6 and 7

• Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7

  Baseline, Weeks 3, 4, 5, 6 and 7

Study Arms (2)

Pregabalin

EXPERIMENTAL

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

pregabalin DRUG

controlled release tablet; 165-495 mg/day; given once daily

Pregabalin

placebo DRUG

matching placebo tablet; given once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have fibromyalgia.

You may not qualify if:

• Patients with other painful conditions cannot participate.

Sponsors & Collaborators

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

Study Sites (52)

Andrew O. Schreiber, MD

Orange, California, 92868, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Paddock Park Clinical Research

Ocala, Florida, 34474, United States

Location

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Arthritis Care Center

Moline, Illinois, 61265, United States

Location

Davis Clinic, Inc

Indianapolis, Indiana, 46250, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

The Center for Pharmaceutical Research, PC

Kansas City, Missouri, 64114, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

Albuquerque Neuroscience, Incorporated

Albuquerque, New Mexico, 87109, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Trinity Health Organization

Minot, North Dakota, 58701, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Radiant Research,

Columbus, Ohio, 43212, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

East Penn RheumatologyAssociates, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Fatigue Consultation Clinic

Salt Lake City, Utah, 84102, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Tacoma Center for Arthritis Research, PS

Tacoma, Washington, 98405-2308, United States

Location

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, V2A 4M4, Canada

Location

Rivergrove Medical Clinic

Winnipeg, Manitoba, R2V 4W3, Canada

Location

Maritime Research Center

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Clinique Medicale Nepisiguit

Bathurst, New Brunswick, E2A 4Z9, Canada

Location

Tri-Hospital Sleep Laboratory West

Mississauga, Ontario, L5B 4M4, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

Location

Sleep & Alertness Research Inc.

Toronto, Ontario, M6J 3S3, Canada

Location

West Island Rheumatology Research Associates

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Groupe de Recherche en Rhumatologie et Maladie Osseuses (GRMO Inc.)

Québec, Quebec, G1V 3M7, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Mahavir Hospital & Research Centre

Hyderabad, Andhra Pradesh, 500 004, India

Location

Chanre Rheumatology & Immunology Center & Research

Bangalore, Karnataka, 560 079, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411 004, India

Location

Sahyadri Clinical Research & Development Center,

Pune, Maharashtra, 411 004, India

Location

Sahyadri Speciality Hospital

Pune, Maharashtra, 411004, India

Location

Punjab Rheumatology Centre

Ludhiana, Punjab, 141 001, India

Location

Department of Rheumatology

Lucknow, Uttar Pradesh, 226 018, India

Location

Indian Spinal Injuries Centre

New Delhi, 110 070, India

Location

Chang Gung Medical Foundation-Linkou Branch

Kwei Shan Town, Taoyuan County, 333, Taiwan

Location

Chang-Hua Christian Hospital

Changhua, 500, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24867298 DERIVED

Related Links

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

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 7, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 22, 2021
• Results First Posted: September 14, 2018

Record last verified: 2018-08

Locations

TW (4); US (30); IN (8); CA (10)