UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012503 |
|---|---|
| Receipt number | R000014611 |
| Scientific Title | Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2015/07/17 11:50:19 |
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Basic information
Public title
Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study
Acronym
Creatine in SBMA
Scientific Title
Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study
Scientific Title:Acronym
Creatine in SBMA
Region
| Japan |
Condition
Condition
Spinal and Bulbar Muscular Atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the creatine supplementation in SBMA patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Grip power
Key secondary outcomes
(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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Creatine monohydrate 10 g, daily for 8 weeks
Interventions/Control_2
Creatine monohydrate 15 g, daily for 8 weeks
Interventions/Control_3
placebo for 8 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. Patients (males) whose number of the CAG repeat in the androgen receptor gene is more than 38
2. Patients with muscle weakness
3. Patients are between 20 and 80 years old at the time of the agreement acquisition
4. Patients who are capable of ambulatory hospital visits
5. Patients whose renal functions meet the following criteria:
Serum creatinine: <1.5 * Upper Limit of Institutional Reference Value
6. Patients with written informed consent
Key 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
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
TEL
052-744-2385
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Hijikata |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
TEL
052-744-2390
Homepage URL
hijikata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋大学医学部附属病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 05 | Day |
Last modified on
| 2015 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014611
