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GW679769 In Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264628
First received: December 9, 2005
Last updated: April 15, 2015
Last verified: April 2015
History of Changes
December 9, 2005
April 15, 2015
October 2005
September 2006   (Final data collection date for primary outcome measure)
Change in Fibromyalgia Impact Questionnaire (FIQ) total score [ Time Frame: throughout study ]
Change in Fibromyalgia Impact Questionnaire (FIQ) total score from start to end of treatment.
Complete list of historical versions of study NCT00264628 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Effect of GW679769 vs placebo in health-related quality of life outcomes.
  • Relationship between PK of GW679769 and clinical outcome in patients.
  • Safety and Tolerability
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GW679769 In Fibromyalgia
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.
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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Observational
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  • Depressive Disorder
  • Depression
  • Fibromyalgia
Drug: GW679769
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2006
September 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Italy
 
NCT00264628
SND103929
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GlaxoSmithKline
GlaxoSmithKline
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Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP