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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01490905
Eligibility Criteria:
Inclusion Criteria:
1. Back pain lasting greater than six (6) weeks. Pain must be present on at least 5 out of 7 days during each of the two weeks prior to screening visit
2. Analgesic medication used to treat pain at least 4 out of last 7 days and at least 10 days in the last month
3. Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent, with diagnosis of back pain and baseline back pain greater than 40 mm out of 100 mm on visual analog scale
4. Those taking an NSAID for pain must discontinue use during a washout period based on the attached five (5) half-lives of drug chart
5. If undergoing physical therapy for back pain, therapy must be stable at least three (3) weeks prior to study and remain the same throughout study
6. If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-convulsants-), treatment must be stable for at least three (3) months prior to study
7. For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study
8. Must be willing to commit to all clinical visits during study-related procedures, including required discontinuation (washout) of analgesic or anti-inflammatory medication prior to Day 1 randomization. The patient must agree to using acetaminophen for rescue medication
Exclusion Criteria:
1. Patients with back surgery in the past six (6) months
2. Patients with significant neurologic impairment, as diagnosed on screening physical examination
3. Patients with evidence or history of fracture of the spine in the past year
4. Patients not fluent in English
5. Use of aspirin for non-arthritic conditions, unless at a dose less than or equal to 325 mg a day, and must be stable for at least one (1) month prior to screening
6. Use of controlled substances and/or opiate analgesic for pain, for more than 5 days within the last 30 days prior to screening visit
7. Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening
8. Participation in a clinical trial within the one (1) month prior to screening
9. History of epidurals in the past three (3) months
10. History of alcohol or substance abuse
11. Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal or urogenital, endocrine, neurologic or psychiatric disorder
12. History of gastrointestinal bleed or documented gastric or duodenal ulcer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01490905
Study Brief:
Protocol Section:
NCT01490905