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Completed

NCT Number: NCT00612170

A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

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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, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female of any race, at least 18 years of age
  • Patients must meet the 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)

Exclusion criteria

  • Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
  • A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
  • History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

Treatment and study plan

[S,S]-Reboxetine

Drug

10 mg oral tablet once a day dosing

Placebo

Drug

0 mg oral tablet once a day dosing

Primary outcomes

  1. Change from baseline in the endpoint mean pain score

    Time frame: 14 weeks

  2. Fibromyalgia Impact Questionnaire

    Time frame: 14 weeks

Secondary outcomes

  1. Change from baseline in the endpoint mean sleep interference score

    Time frame: 14 weeks

  2. Patient Global Impression of Change

    Time frame: 14 weeks

  3. Multidimensional Assessment of Fatigue

    Time frame: 14 weeks

  4. Hospital Anxiety and Depression Scale

    Time frame: 14 weeks

  5. Short Form 36

    Time frame: 14 weeks

  6. Sheehan Disability Score

    Time frame: 14 weeks

  7. Pain Visual Analogue Scale

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2008
Registry last updated
Dec 12, 2019

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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