Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00256893
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00256893
Study Brief:
Protocol Section:
NCT00256893