JRCT ID: jRCTs031220709
Registered date:16/03/2023
Clinical research on neurotropin tablets in low back pain patients with sarcopenia
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Low back pain with sarcopenia |
Date of first enrollment | 08/06/2023 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Study drug: Oral administration of 2 Neurotropin tablets twice a day (morning and evening) for 12 weeks Control drug: Oral administration of two placebo tablets twice a day (morning and evening) for 12 weeks |
Outcome(s)
Primary Outcome | Change in 4-meters walking speed after 12 weeks of administration from before administration |
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Secondary Outcome | (1) Changes from before the start of administration in 4-meters walking speed at 4 weeks and 8 weeks after administration (2) Changes from before the start of administration in the following indicators at 4 weeks, 8 weeks, and 12 weeks after administration Skeletal muscle mass by BIA method, grip strength, BMI, five-time chair rise time, balance test, lower leg circumference, SPPB (comprehensive score calculated from three tests: walking speed, time to rise from chair, balance test), QOL questionnaire EQ-5D-5L score (3) Changes from before the start of administration in lumbago VAS values at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks after administration |
Key inclusion & exclusion criteria
Age minimum | >= 65age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | (1) Patients diagnosed with low back pain by the investigator (2) Patients aged 65 or older at the time of obtaining consent (3) Regardless of gender (4) Patients who meet all of the following criteria 1. Grip strength Less than 28 kg for male, less than 18 kg for female. 2. 4m walking speed Walking speed <1.0m/s 3. Skeletal muscle mass Less than 7.0 kg/m2 for male (BIA method) Less than 5.4 kg/m2 for female (BIA method) (5) Patients who have given written informed consent of their own free will after receiving a sufficient explanation for participating in this research (6) Patients who are able to go to the outpatient clinic according to the study schedule (7) Patients who can comply with the regulations for prohibited concomitant drugs and prohibited concomitant therapies (see ''7.4.1 Prohibited concomitant drugs and prohibited concomitant therapies'') |
Exclude criteria | Those who meet even one of the following exclusion criteria will be excluded from subjects to be registered. (1) Patients with a history of hypersensitivity to the study drug (2) Patients with significant cognitive decline or mental illness (3) Patients who have difficulty using devices used for efficacy evaluation due to their physique, etc. (4) Patients who continue to administer preparations containing vaccinia virus-inoculated rabbit skin extract (5) Patients whose results of laboratory tests meet the following conditions 1. ALT is 2.5 times or more of the upper limit of the reference value 2. AST is 2.5 times or more of the upper limit of the reference value (6) Those who have participated in other clinical trials or clinical research (excluding observational studies) within 6 months prior to written consent (7) Patients with diseases that should be prioritized for treatment other than frailty or sarcopenia due to low back pain (8) In addition, those who are judged inappropriate to participate in this study by the principal investigator or co-investigator |
Related Information
Primary Sponsor | Sumitani Masahiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | Nippon Zoki Pharmaceutical Co., Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Masahiko Sumitani |
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Tokyo Japan 113-8655 |
Telephone | +81-3-3815-5411 |
sumitanim-ane@g.ecc.u-tokyo.ac.jp | |
Affiliation | The University of Tokyo Hospital |
Scientific contact | |
Name | Masahiko Sumitani |
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Tokyo Japan 113-8655 |
Telephone | +81-3-3815-5411 |
sumitanim-ane@g.ecc.u-tokyo.ac.jp | |
Affiliation | The University of Tokyo Hospital |