GW679769 In Fibromyalgia

Tracking Information
First Submitted Date	December 9, 2005
First Posted Date	December 13, 2005
Last Update Posted Date	April 16, 2015
Study Start Date	October 2005
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 7, 2007)	Change in Fibromyalgia Impact Questionnaire (FIQ) total score [ Time Frame: throughout study ]
Original Primary Outcome Measures; (submitted: December 12, 2005)	Change in Fibromyalgia Impact Questionnaire (FIQ) total score from start to end of treatment.
Change History	Complete list of historical versions of study NCT00264628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 7, 2007)	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 ]
Original Secondary Outcome Measures; (submitted: December 12, 2005)	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
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	GW679769 In Fibromyalgia
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.
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Depressive Disorder; Depression; Fibromyalgia
Intervention	Drug: GW679769
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 7, 2007)	8
Original Enrollment; (submitted: December 12, 2005)	50
Actual Study Completion Date	September 2006
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries	Italy
Administrative Information
NCT Number	NCT00264628
Other Study ID Numbers	SND103929
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	GlaxoSmithKline
Study Sponsor	GlaxoSmithKline
Collaborators	Not Provided
Investigators	Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	April 2015