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OpenTrials
Completed

NCT Number: NCT00264628

GW679769 In Fibromyalgia

The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Fibromyalgia Mental Disorders Mood Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of fibromyalgia (ACR criteria).
  • Non-severe depression (HAM-D score >14 <24).
  • Women must commit to consistent use of an acceptable method of birth control.

Exclusion criteria

  • Severe depression (HAM-D score > 24).
  • Unable to discontinue medications for pain or depression.
  • Laboratory and ECG value at screening outside sponsor defined ranges.
  • Positive to stool occult blood test.

Treatment and study plan

GW679769

Drug

Primary outcomes

  1. Change in Fibromyalgia Impact Questionnaire (FIQ) total score

    Time frame: throughout study

Secondary outcomes

  1. Effect of GW679769 vs placebo in health-related quality of life outcomes

    Time frame: throughout study

  2. Relationship between PK of GW679769 and clinical outcome in patients

    Time frame: throughout study

  3. Safety and Tolerability

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Outpatient, Randomised, Double-blind, Placebo Controlled, Parallel Group Exploratory Study to Evaluate Safety, Tolerability and Efficacy of GW679769 in Patients With Fibromyalgia Syndrome Comorbid With Depression.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 13, 2005
Registry last updated
Apr 16, 2015

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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