Study of REN-1654 in Patients With Sciatica Pain (NCT00107055) | Clinical Trial Compass
UnknownPhase 2
Study of REN-1654 in Patients With Sciatica Pain
United States72 participantsStarted 2003-12
Plain-language summary
The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that is causing compression on the nerves coming out of the spinal column.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Males or females, ages 18 to 55, able and willing to provide written informed consent to participate in the study.
* Able to read, understand and follow the study instructions, including completion of pain intensity rating scales.
* Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment.
* Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 24 hour period) of at least 4, using an 11-point categorical pain intensity scale with 0 = no pain and 10 = worst pain imaginable.
* Leg pain on a screening Categorical Pain Intensity Rating rated as more severe than back pain.
* Positive straight leg raising (SLR) test as defined in Appendix B of this protocol.
* Subjects who are compliant in maintaining a Pain Diary between screening and baseline visits, and who record a 24-hour average Categorical Pain Intensity Rating score of at least 4 or greater on at least 3 days during the week prior to baseline visit.
* Subject who can maintain stable pharmacologic treatments for sciatica symptoms taken prior to dosing including analgesics, anti-inflammatory medications (e.g. NSAIDS), antidepressants, anticonvulsants, anxiolytics, or muscle relaxants. Subjects must be on stable doses of such medications for 2 weeks prior to the baseline visit, and maintained on the same doses throu…
What they're measuring
1
Leg Pain: Change in Average Daily 11-Point Categorical Pain Intensity Rating at the end of the 3-week treatment period