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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000012503 |
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Date of registration:
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25/12/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study
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Scientific title:
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Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study - Creatine in SBMA |
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Date of first enrolment:
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2014/06/01 |
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Target sample size:
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45 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014611 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yasuhiro Hijikata |
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Address:
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65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
Japan |
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Telephone:
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052-744-2390 |
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Email:
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hijikata@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Department of Neurology |
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Name:
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Gen Sobue |
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Address:
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65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
Japan |
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Telephone:
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052-744-2385 |
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Email:
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sobueg@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Patients who have taken LH-RH agonists, an LH-RH antagonists, teststerone drugs, anti-androgen drugs, estrogen drugs or unapproved drug within 48 weeks before agreement acquisition and patients who have taken 5-alpha-reductase inhibitors within 24 weeks before agreement acquisition. 2. Patients whose serum testosterone level is below the lower limit of normal. 3. Patients who have taken creatine supplementation within 8 weeks before agreement acquisition 4. Patients who have severe complications 5. Patients who are not appropriate to participate in the trial
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Spinal and Bulbar Muscular Atrophy
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Intervention(s)
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Creatine monohydrate 10 g, daily for 8 weeks
Creatine monohydrate 15 g, daily for 8 weeks
placebo for 8 weeks
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Primary Outcome(s)
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Grip power
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Secondary Outcome(s)
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(1) Muscle strength measured by quantitative muscle testing (2) Motor function: tongue pressure, Timed walk test, Rise from bed test, and modified QMG Score (3) Respiratory function test: vital capacity, forced vital capacity, forced expiratory volume one second percent, peak expiratory flow and V50/V25 (4) Activities of daily living(ADL) assessed by ALSFRS-R and SBMAFRS questionnaires (5) Swallowing Disturbance Questionnaire (6) Quality of life questionnaires: SWAL-QOL and ALSAQ-5 (7) Multidimensional Fatigue Inventory (8) Muscle mass measured by dual-energy X-ray absorptiometry (9) urinary 8-OHdG
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Source(s) of Monetary Support
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Japan Society for the Promotion of Science
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Center for Advanced Medicine and Clinical Research, Nagoya University Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2015 |
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URL:
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