Pain caused by radiculopathy due to lumbar spinal stenosis
Conditions
Interventions
investigational material(s)
Generic name etc : DS-1971a
INN of investigational material :
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administrati
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects who are able to understand the study procedures, complete the electronic patient diary and electronic patient questionnaire, and appropriately answer the physician's questions. -Subjects who have lower limb pain caused by radiculopathy that has been persisting for at least 3 months before the start day of the screening period and that can be explained by lumbar spinal stenosis found by magnetic resonance imaging (MRI).
Exclusion criteria
Exclusion criteria: -Subjects who have undergone any lumbar surgery or require any lumbar surgery during the study period. -Subjects who have any disease that may affect the evaluation of pain of lower limbs (ASO, rheumatoid arthritis, diabetic peripheral neuropathy, etc.). -Subjects who have undergone any brain or spinal cord surgery or require any brain or spinal cord surgery during the study period -Subjects who have central neuropathic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily pain score To compare the change from baseline in the weekly average daily pain score at end of treatment of DS-1971a to that for placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| HADS , SF-36 To compare the change from baseline in the HADS and SF-36 at end of treatment of DS-1971a to that for placebo. | — |
Outcome results
None listed