Last updated: 11/04/2018 12:28:58
GW679769 In Fibromyalgia
GSK study ID
SND103929
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Timeframe: throughout study
Secondary outcomes:
Effect of GW679769 vs placebo in health-related quality of life outcomes
Timeframe: throughout study
Relationship between PK of GW679769 and clinical outcome in patients
Timeframe: throughout study
Safety and Tolerability
Timeframe: throughout study
Interventions:
Drug: GW679769
Enrollment:
8
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder, Fibromyalgia
Product
casopitant
Collaborators
Not applicable
Study date(s)
October 2005 to September 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosis of fibromyalgia (ACR criteria).
- Non-severe depression (HAM-D score >14 <24).
- Severe depression (HAM-D score > 24).
- Unable to discontinue medications for pain or depression.
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2006-11-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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