UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020589 |
|---|---|
| Receipt number | R000023769 |
| Scientific Title | Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2017/03/05 18:20:54 |
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Basic information
Public title
Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Acronym
Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Scientific Title
Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Scientific Title:Acronym
Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Region
| Japan |
Condition
Condition
Japanese adult without clinical and radiographic evidence of knee osteoarthritis
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of N-acetyl-glucosamine on the cartilage metabolism and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in C2C/PIICP (weeks 16 during the intervention)
chnge in C2C/PIICP (weeks 8 and 12 during the intervention, weeks 8 after intervention)
Key secondary outcomes
change in C2C (weeks 8, 12 and 16 during the intervention, weeks 8 after intervention)
change in PIICP (weeks 8, 12 and 16 during the intervention, weeks 8 after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
N-acetyl-glucosamine (500 mg/day, weeks 16 during the intervention)
Interventions/Control_2
Placebo (500 mg/day, weeks 16 during the intervention)
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese adult (aged 40-74) without clinical and radiographic evidence of knee osteoarthritis
Key exclusion criteria
1.Subjects with gout or rheumatoid arthritis
2.Subjects with surgical treatment of joint performed or its necessity
3.Subjects with routine use of health foods which are good for bone or joint
4.Subjects with the presence of any clinically significant conditions judged by the medical investigator to preclude the subject's participation in the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mihoko Kurokawa |
Organization
Q' SAI CO.,LTD.
Division name
Research Department
Zip code
Address
1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, JAPAN
TEL
092-724-0855
kurokawa@kyusai.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakagawa |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
Q' SAI CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
Q' SAI CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 15 | Day |
Last modified on
| 2017 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023769
