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Trial record 87 of 284 for:    impact | "Fibromyalgia"

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.
ClinicalTrials.gov Identifier: NCT00264628
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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