UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005635 |
|---|---|
| Receipt number | R000006658 |
| Scientific Title | Study about efficacy and safety of opioids as analgesics for patients with osteoarthritis |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/24 11:40:29 |
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Basic information
Public title
Study about efficacy and safety of opioids as analgesics for patients with osteoarthritis
Acronym
Usefulness of opioids for osteoarthritis
Scientific Title
Study about efficacy and safety of opioids as analgesics for patients with osteoarthritis
Scientific Title:Acronym
Usefulness of opioids for osteoarthritis
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of opioids
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Opioids
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with symptomatic patients for at least 12 weeks who experienced at least modelate pain (VAS score is at least 40mm) despite treatment with non-steroidal anti-inflammatory drugs
Key exclusion criteria
Exclusion criteria included a history of alcohol or drug abuse; surgical procedure within 30 days involving the target joint; or any known allergy, sensitivity, or contraindication to a study medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Soen |
Organization
Nara Hospital, Kinki University School of Medicine
Division name
Department of Orthopaedic Surgery and Rheumatology
Zip code
Address
1248-1, Otodacho, Ikoma, Nara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nara Hospital, Kinki University School of Medicine
Division name
Department of Orthopaedic Surgery and Rheumatology
Zip code
Address
1248-1, Otodacho, Ikoma, Nara
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery and Rheumatology, Nara Hospital, Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical Company
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
| 2011 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 24 | Day |
Last modified on
| 2011 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
