- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264628
GW679769 In Fibromyalgia
April 15, 2015 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
8
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Fibromyalgia Impact Questionnaire (FIQ) total score
Time Frame: throughout study
|
throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of GW679769 vs placebo in health-related quality of life outcomes
Time Frame: throughout study
|
throughout study
|
Relationship between PK of GW679769 and clinical outcome in patients
Time Frame: throughout study
|
throughout study
|
Safety and Tolerability
Time Frame: throughout study
|
throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
December 9, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (Estimate)
December 13, 2005
Study Record Updates
Last Update Posted (Estimate)
April 16, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Depression
- Depressive Disorder
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Casopitant
Other Study ID Numbers
- SND103929
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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