Clinical effect of NTN tablets on lumbar spinal canal stenosis with low back pain

JRCT ID: jRCTs031200282

Registered date:04/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lumber Spinal Canal Stenosis
• Date of first enrollment: 05/04/2021
• Target sample size: 69
• Study type: Interventional

Intervention(s)

Patients enroll in the below 3 arms and administrate each study drug for 12 weeks.
1) Neurotropin (N) arm : 2 NTN tablets, twice a day (after breakfast and dinner)
2) Limaprost (L) arm: 1 Limaprost Alfadex tablet, 3 times a day (after breakfast, lunch and dinner)
3) Neurotropin Limaprost (NL) arm : 2 NTN tablets, twice a day (after breakfast and dinner) and 1 Limaprost Alfadex tablet, 3 times a day (after breakfast, lunch and dinner)

Outcome(s)

• Primary Outcome: VAS change of inferior limb pain from Visit 3 to 9

Secondary Outcome

<Efficacy Secondary Outcomes>
1) The amount of change in VAS from Visit4 to Visit9 for 3days before the baseline (VAS for 3days before Visit3) for the lower limb pain.
2) The amount of change in VAS from Visit4 to Visit9 for 3days before the baseline (VAS for 3days before Visit3) for the numbness of the lower limbs.
3)The amount of change in VAS from Visit4 to Visit9 for 3days before the baseline (VAS for 3days before Visit3) for the low back pain.
4) The amount of change in the Gait-related activity (20seconds walking speed, gait & balance, 3m timed up and go test, 5times standing up) from Visit4 to Visit9 based on the Visit3 score at each measured value.
5) Quality of Life (QOL) (ODI, EQ-5D-5L, RDQ, PCS, PSEQ)in Visit5, Visit7, and Visit9 based on the Visit3 score at each measured value.
<Safety Secondary Outcomes>
Occurrence rate of Adverse Events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who receive enough explanation about this study and sign written informed consents
2) Patients whose ages are over 20 years old
3) Patients who have low back pain
4) Patients with lumbar spinal canal stenosis checked with MRI
5) Patients with intermittent claudication
6) Patients who fill with the below conditions for clinical test results before the registration
(1) ALT is less than 2.5 times the upper limit of the normal range
(2) AST is less than 2.5 times the upper limit of the normal range
7) Patients who have not received the below drugs before obtaining consent
(1) Within 12 weeks before obtaining consent
a) An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus
b) Limaprost Alfadex
c) Study drug or other study drug under clinical study
(2) Within 7 days before obtaining consent
a) Prostaglandin formulation

Exclude criteria

1) Patients with a surgical history of lumbar spinal tube
2) Suitable patients for surgery of lumbar spinal canal stenosis
3) Patients with spinal disc herniation
4) Patients with peripheral arterial occlusive disease
5) Patients who have or are suspected of peripheral neuropathy (diabetic, alcoholic and drug-induced etc.)
6) Patients with other gait disorders that have possible influence on effectiveness assessment, and patients who have pain and numbness in lumbar which are not caused by lumbar spinal canal stenosis
7) Patients who have nerve root block injections which may affect efficacy evaluation within 3 months before obtaining consent, or who plan to have the injection during the study period after obtaining consents
8) Patients with a history of hypersensitivity for An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus and Limaprost Alfadex
9) Patients who show symptoms associated with cerebropathy, cerebral infarction and cerebral hemorrhage, or have shown within 6 months after administration of study drugs
10) Patients who have or history of compilations of convulsive seizure or epileptic seizure
11) Patients who have severe respiratory diseases, cardiac diseases, kidney diseases, liver diseases and hematologic diseases
12) Patients who have mental disorder including depression, and who are judged to be significant danger by participating in the study, by a research representative physician or a research physician
13) Women who are pregnant, lactating, and pregnancy potential, or who hope to be pregnant during this study
14) Patients who take other study drugs and investigational agents within 12 weeks after starting study drugs administration
15) Others, patients who are judged as unsuitable for participating, by a research representative physician or a research physician

Related Information

• Primary Sponsor: Eguchi Yawara
• Source(s) of Monetary Support: Nippon Zoki Pharmaceutical Co., Ltd