Back to resultsGW679769 In Fibromyalgia
Primary Purpose
Depressive Disorder, Depression, Fibromyalgia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
GW679769
Sponsored by
About this trial
This is an observational trial for Depressive Disorder focused on measuring NK1-antagonist, Depression, Fibromyalgia, GW679769, Outpatient
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00264628
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.
Study Type
Observational
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression, Fibromyalgia
Keywords
NK1-antagonist, Depression, Fibromyalgia, GW679769, Outpatient
7. Study Design
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW679769
Primary Outcome Measure Information:
Title
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Effect of GW679769 vs placebo in health-related quality of life outcomes
Time Frame
throughout study
Title
Relationship between PK of GW679769 and clinical outcome in patients
Time Frame
throughout study
Title
Safety and Tolerability
Time Frame
throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
GW679769 In Fibromyalgia
We'll reach out to this number within 24 hrs