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GW679769 In Fibromyalgia

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 9, 2005
Last updated: April 15, 2015
Last verified: April 2015
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 Intervention
Depressive Disorder Depression Fibromyalgia Drug: GW679769

Study Type: Observational
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.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Effect of GW679769 vs placebo in health-related quality of life outcomes [ Time Frame: throughout study ]
  • Relationship between PK of GW679769 and clinical outcome in patients [ Time Frame: throughout study ]
  • Safety and Tolerability [ Time Frame: throughout study ]

Enrollment: 8
Study Start Date: October 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00264628

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00264628     History of Changes
Other Study ID Numbers: SND103929
Study First Received: December 9, 2005
Last Updated: April 15, 2015

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017