Depressive DisorderNCT00264628
GW679769 In Fibromyalgia
An observational study of Depressive Disorder and Depression, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Depression, Fibromyalgia
- What is being tested?
- GW679769
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
- Conditions
- Depressive Disorder, Depression, Fibromyalgia
- Being tested
- GW679769
- Keywords
- NK1-antagonist, Depression, Fibromyalgia, GW679769, Outpatient
- Medical subject headings
- Depressive Disorder, Depression, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Measured: throughout study
Secondary outcomes (3)
Effect of GW679769 vs placebo in health-related quality of life outcomes
Measured: throughout study
Relationship between PK of GW679769 and clinical outcome in patients
Measured: throughout study
Safety and Tolerability
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264628
- Sponsor's protocol ID
- SND103929
- Status last verified
- Apr 2015
- First submitted
- 9 Dec 2005
- Last updated
- 16 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00264628
- Acronym / sponsor ID
- SND103929
- Conditions
- Depressive Disorder, Depression, Fibromyalgia
- Keywords
- NK1-antagonist, Depression, Fibromyalgia, GW679769, Outpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 13 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 | Drug | – |
Primary outcome
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Time frame: throughout study
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Depression, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire (FIQ) total score (time frame: throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.