UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001027 |
|---|---|
| Receipt number | R000001239 |
| Scientific Title | The effects of collagen and hyaluronic acid for osteoarthritis symptoms study (CHAOS study), OCU-0704 |
| Date of disclosure of the study information | 2008/02/23 |
| Last modified on | 2012/11/28 21:35:16 |
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Basic information
Public title
The effects of collagen and hyaluronic acid for osteoarthritis symptoms study (CHAOS study), OCU-0704
Acronym
CHAOS study, OCU-0704
Scientific Title
The effects of collagen and hyaluronic acid for osteoarthritis symptoms study (CHAOS study), OCU-0704
Scientific Title:Acronym
CHAOS study, OCU-0704
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary endpoint is the improvement of knee pain by taking the hyaluronic acid / collagen for the men and women who have the pain in the knee. Also to reveal the effects of the hyaluronic acid / collagen on lumbar pain and bone metabolism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
WOMAC score, joint narrowing of the knee (MTP view), SF-36, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ)
Key secondary outcomes
Bone metabolic marker (BAP, NTx), cartilage metabolic marker (COMP)
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Period: 48 weeks
Intervention group: the examination food (pigskin extraction collagen peptide 90.2%, hyaluronic acid 0.3%, mucopolysaccharides 0.8%, and water 8.7%) is taken, 5g a day.
Interventions/Control_2
Control group: Hydrolysate of corn starch (maltodextrin) is taken. 5g a day
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Knee pain
Key exclusion criteria
artificial replacement of the knees, current use of NSAIDs, current use of steroid, rheumatoid arthritis patients, severe inflammation (ESR>=40mm/h or RF positive), intraarticular injection to the knees within 3 months, abnormal function of liver and kidney (2.5 times or more normal value), intake of alternative medicine (glcosamin, chondroitin sulfate, collagen, and hyaluronic acid) within 4 weeks, remarkable obesity (BMI>30), pregnant or nursing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Koike |
Organization
Osaka City University Medical School
Division name
Department of Rheumatosurgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekichi Tokai |
Organization
Osaka City University Hospital
Division name
Center for Drug & Food Clinical Evaluation
Zip code
Address
Abenoku Asahimachi 1-2-7, Osaka, 545-8585, Japan
TEL
06-6645-3440
Homepage URL
http://www.med.osaka-cu.ac.jp/hosp/self/hyokac/shokuhin/shokuhinsiken.html
tokai@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyusai Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 02 | Month | 23 | 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
| 2008 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 13 | Day |
Last modified on
| 2012 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001239
