NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedLow back pain with sarcopenia
Date of first enrollment08/06/2023
Target sample size50
Countries of recruitment
Study typeInterventional
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 OutcomeChange in 4-meters walking speed after 12 weeks of administration from before administration
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
Age maximumNot applicable
GenderBoth
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 criteriaThose 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

Contact

Public contact
Name Masahiko Sumitani
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo Tokyo Japan 113-8655
Telephone +81-3-3815-5411
E-mail 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
E-mail sumitanim-ane@g.ecc.u-tokyo.ac.jp
Affiliation The University of Tokyo Hospital