GW679769 In Fibromyalgia
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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. |
ClinicalTrials.gov Identifier: NCT00264628 |
Recruitment Status
:
Completed
First Posted
: December 13, 2005
Last Update Posted
: April 16, 2015
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | ||||
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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 |
Change in Fibromyalgia Impact Questionnaire (FIQ) total score [ Time Frame: throughout study ] | |||
Original Primary Outcome Measures |
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 |
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Original Secondary Outcome Measures |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
8 | |||
Original Enrollment |
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:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (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 |
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PRS Account | GlaxoSmithKline | |||
Verification Date | April 2015 |