GW679769 In Fibromyalgia

• Sponsor: GlaxoSmithKline
• 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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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

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