Fibromyalgia Study In Adults

Launched by GLAXOSMITHKLINE · Nov 21, 2005

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
• • Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
• • Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
• • Only subjects experiencing moderate/severe pain (pain intensity score \>= 4 on the pain numerical rating scale) will be eligible for this study.
• • Subjects that are generally well.
• • Have the ability to discontinue prohibited medications for the duration of the study.
• Exclusion criteria:
• • Subjects with 'flare' of arthritic conditions.
• • Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
• • History of drug and/or alcohol abuse or major depression.