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GW679769 In Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264628
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Depressive Disorder Depression Fibromyalgia Drug: GW679769

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Study Type : Observational
Actual Enrollment : 8 participants
Official 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.
Study Start Date : October 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Primary Outcome Measures :
  1. Change in Fibromyalgia Impact Questionnaire (FIQ) total score [ Time Frame: throughout study ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264628

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT00264628     History of Changes
Other Study ID Numbers: SND103929
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
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Depressive Disorder
Myofascial Pain Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action