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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT00904020
Eligibility Criteria:
Inclusion Criteria:
* Were currently receiving an analgesic regimen that contained gabapentin
* Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
* Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of \>4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory \[BPI\] within 24 hours prior to the screening visit
* For diabetic patients, had a hemoglobin A1c level \<0.13 (normal range, 0.047-0.064)
Exclusion Criteria:
* Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
* Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
* Had received trigger point injections within 14 days prior to study entry
* Had received Botox injections within 3 months prior to study entry
* Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
* Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00904020
Study Brief:
Protocol Section:
NCT00904020