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

NCT00333866 | Completed Phase 3 Results

• 1 other identifier: A0081100
• Study Type: interventional
• Target: 747
• Locations: 16 countries
• Sites: 74

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)

  Baseline, Week 14

• Change From Baseline in Weekly Mean Sleep Quality Score

  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

  Baseline, Week 14

• Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14

  Baseline, Week 14

• Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14

  Baseline, Week 14

Study Arms (4)

1

EXPERIMENTAL

Drug: pregabalin

2

EXPERIMENTAL

Drug: pregabalin

3

EXPERIMENTAL

Drug: pregabalin

4

PLACEBO COMPARATOR

Drug: placebo

Interventions

pregabalin DRUG

600mg/day

1

placebo DRUG

placebo

4

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients with other severe pain conditions
• Patients with severe depression
• Patients taking excluded medications

Sponsors & Collaborators

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

Study Sites (74)

Pfizer Investigational Site

Warrawong, New South Wales, 2502, Australia

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Maroochydore, Queensland, 4558, Australia

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Clayton, Victoria, 3168, Australia

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Fitzroy, Victoria, 3065, Australia

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Kelowna, British Columbia, V1Y 2H4, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Bathurst, New Brunswick, E2A 4X7, Canada

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St. John's, Newfoundland and Labrador, A1B 3E1, Canada

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Hawkesbury, Ontario, K6A 1A1, Canada

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Toronto, Ontario, M3K 2A7, Canada

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Drummondville, Quebec, J2B 7T1, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Québec, Quebec, G1V 3M7, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Frederiksberg, 2000, Denmark

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Svendborg, 5700, Denmark

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Montpellier, Cedex 5, 34295, France

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Lille, Cedex, 59037, France

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Clermont-Ferrand, 63003, France

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Paris, 75181, France

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Saint-Etienne, 42055, France

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Bad Säckingen, 79713, Germany

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Berlin, 10117, Germany

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Berlin, 14109, Germany

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Bonn, 53105, Germany

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Mannheim, 68161, Germany

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München, 80336, Germany

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Indore, Madhya Pradesh, 452001, India

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Ludhiana, Punjab, 141 001, India

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Ludhiana, Punjab, 141 008, India

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Lucknow, Uttar Pradesh, 226 014, India

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Bari, 79124, Italy

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Benevento, 82100, Italy

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Bologna, 40138, Italy

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Chieti Scalo, 66013, Italy

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Perugia, 06100, Italy

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Pisa, Italy

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México, D. F., 14080, Mexico

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León, Guanajuato, 37520, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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San Luis Potosí City, 78240, Mexico

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Alkmaar, 1815 JD, Netherlands

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Den Helder, 1782 GZ, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Zwolle, 8011 JW, Netherlands

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Lisbon, 1050-054, Portugal

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Lisbon, 1249-075, Portugal

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Lisbon, 1349-019, Portugal

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Lisbon, 1700-360, Portugal

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Suwon, Kyeongki-do, 442-712, South Korea

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Seoul, 133-792, South Korea

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Seoul, 143-914, South Korea

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Barcelona, 08024, Spain

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Barcelona, 08035, Spain

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Córdoba, 14004, Spain

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Guadalajara, 19002, Spain

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Linköping, 581 85, Sweden

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Mölndal, 431 37, Sweden

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Örebro, 701 85, Sweden

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Stockholm, SE-112 81, Sweden

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Lausanne, 1011, Switzerland

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Zurich, 8063, Switzerland

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Zurich, 8091, Switzerland

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Manchester, Greater Manchester, M6 8HD, United Kingdom

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Greenock, Renfrewshire, PA16 0XN, United Kingdom

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North Shields, Tyne and Wear, NE29 8NH, United Kingdom

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London, WC1X 8LD, United Kingdom

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Poole, BH12 2JB, United Kingdom

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Caracas, Distrito Federal, 1010, Venezuela

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Caracas, Distrito Federal, 1060, Venezuela

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Caracas, Miranda, 1081, Venezuela

Location

Related Publications (5)

• 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.

  PMID: 26694975 DERIVED

• 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.

  PMID: 21965636 DERIVED

• 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.

  PMID: 21639874 DERIVED

• 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.

  PMID: 21039311 DERIVED

• 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.

  PMID: 20584327 DERIVED

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

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: Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: July 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 11, 2021
• Results First Posted: May 13, 2009

Record last verified: 2009-03

Locations

IT (6); CA (12); SE (4); AU (4); FR (5); CH (3); GB (5); DE (6); KR (3); VE (3); ES (4); PT (4); IN (4); DK (2); NL (5); ME (4)