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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT01553318
Eligibility Criteria:
Inclusion Criteria:
In order to qualify the subject:
1. must have been diagnosed with fibromyalgia by a medical doctor
2. must be between the ages of 18 to 65 years of age
3. must have a weekly overall body pain average score ≥ 4
4. must pass a screening questionnaire that calculates a physical impairment of ≥ 10
5. must be on stable doses of his/her current medication for at least past four weeks
6. must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary
7. must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team
8. must be willing to maintain a medication diary provided to him/her during the 10-week study period
9. must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
10. must agree to use a proven method of contraception to prevent pregnancy throughout this study
Exclusion Criteria:
The subject will not be allowed to participate if:
1. he/she has a history of seizures
2. he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
3. he/she has chronic thrombocytopenia (a low blood platelet count)
4. she is currently pregnant, are planning to become pregnant, or is breastfeeding
5. he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
6. he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases)
7. he/she plans to undergo an elective surgery within the study timeline
8. he/she is in the process of filing, or plan to file for disability benefits within the study timeline
9. his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count)
10. he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01553318
Study Brief:
Protocol Section:
NCT01553318