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Completed

NCT Number: NCT00645398

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion criteria

  • Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
  • Patients with severe depression

Treatment and study plan

Pregabalin

Drug

Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Placebo

Drug

Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Primary outcomes

  1. Endpoint mean pain score derived from the subject's daily pain diary

    Time frame: Endpoint

  2. Patient Global Assessment (Patient Global Impression of Change) at Termination Visit

    Time frame: Weeks 5 and 13

  3. Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit

    Time frame: Baseline and Weeks 5, 9, and 13

Secondary outcomes

  1. Change from baseline in FIQ scores at Weeks 5, 9, and 13

    Time frame: Baseline and Weeks 5, 9, and 13

  2. Change from baseline in SDS scores at Weeks 5, 9, and 13

    Time frame: Baseline and Weeks 5, 9, and 13

  3. Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13

    Time frame: Baseline and Weeks 5, 9, and 13

  4. Quality of Sleep Score from the Daily Sleep Diary

    Time frame: Daily

  5. Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13

    Time frame: Baseline and Weeks 5, 9, and 13

  6. Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13

    Time frame: Baseline and Week 13

  7. Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13

    Time frame: Screening, baseline, and Weeks 5, 9, and 13

  8. Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13

    Time frame: Baseline and Weeks 9 and 13

  9. Adverse events

    Time frame: Weeks 1, 2, 5, 9, 13, and at follow-up

  10. Physical examination, including vital signs and weight

    Time frame: Baseline and Week 5 (vital signs only) and 13

  11. Neurological examination

    Time frame: Screening and Week 13

  12. Electrocardiogram

    Time frame: Screening and Week 13

  13. Laboratory tests, including chemistry and hematology

    Time frame: Baseline and Weeks 5, 13, and at follow-up

  14. Urinalysis

    Time frame: Baseline and Weeks 13 and at follow-up

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

Important dates

Study start
2004
Study completion
2005
First posted
Mar 27, 2008
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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