Last updated: 11/04/2018 12:28:58

GW679769 In Fibromyalgia

GSK study ID
SND103929
Clinicaltrials.gov ID
NCT00264628
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    • Inclusion criteria:
    • Diagnosis of fibromyalgia (ACR criteria).
    Inclusion and exclusion criteria
    Inclusion 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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    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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