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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT00488969
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 65
* Diagnosis of traumatic spinal cord injury
* Neuropathic pain (pain related to the nervous system) rated at least 4 on a 11-point numeric rating scale at the time of screening
* Pain classified as at level radicular pain (ALRP), at level central pain (ALCP) or below level central pain (BLCP).
* Pain that is present regularly for at least 3 months prior to enrollment, in spite of medication or other pain treatment. This pain can be paroxysmal in nature (attacks of pain).
* Ability to understand instructions and reliably provide pain assessments
* Willingness to stop current opioid medications, if any
* If a female with childbearing potential, using an approved method of birth control (intrauterine device (IUD), barrier protection, a contraceptive implantation system or injection (Norplant® or Depo-Provera®), oral contraceptive pills, or celibacy)
Exclusion Criteria:
* A known sensitivity to opioids
* A history of substance or alcohol abuse within the past 2 years
* A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period
* Other chronic pain that cannot be differentiated from ALCP, ALRP, or BLCP
* A history of active cancer, excluding basal carcinoma of the skin, in the past 3 years
* Serum creatinine levels \>= 2.5 mg/dl or hepatic (liver) dysfunction with serum ALT, AST, GGT, or total bilirubin \>= 3 times the upper limit of normal
* Participation in any drug study in the last three months
* Currently pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00488969
Study Brief:
Protocol Section:
NCT00488969