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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT01298466
Eligibility Criteria:
Inclusion Criteria:
* Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
* Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
* Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
* Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs \[NSAIDs\]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors \[SNRIs\]) prior to entering the study).
Exclusion Criteria:
* A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of \> 15 on the depression sub-scale only.
* Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance \< 60 mL/min).
* Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
* Patients who have undergone previous surgery for back pain.
* Patients who are using high doses of opioid medication (morphine \> 60 mg per day).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01298466
Study Brief:
Protocol Section:
NCT01298466