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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020589
Receipt No. 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

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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
Email 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
Email t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute Q' SAI CO.,LTD
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023769

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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