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:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT01225068
Eligibility Criteria:
Inclusion Criteria:
1. History of low back pain for a minimum of 6 months with radiation to leg or buttocks
2. Over 18 years of age and under 70
3. Must have a visual analogue scale (VAS) pain score \>50mm
4. Must be in generally stable health
5. Must be willing to abstain from alcohol during the course of the study
6. If female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study
7. Must be able to read and understand instructions and the questionnaires
8. Must be willing to participate in daily data collection requirements via telephone (IVRS)
9. Must understand all aspects of the study, and willing to sign an informed consent form in that regard.
Exclusion Criteria:
1. Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
3. Involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain.
4. Neurological disorder including history of seizures
5. Major psychiatric disorder during the past six months
6. Active suicidal ideation or recent suicidal behavior
7. Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
8. Significant renal disease or severe renal insufficiency
9. History of, or current, substance abuse/dependence
10. Significantly abnormal laboratory values
11. Pregnant or lactating any time during the course of the study
12. Known sensitivity to Savella or other SNRI
13. Glaucoma
14. Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
15. Beck Depression Inventory Score \>30
16. Current Sleep Disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01225068
Study Brief:
Protocol Section:
NCT01225068