UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017405 |
|---|---|
| Receipt number | R000020179 |
| Scientific Title | Pharmacokinetic comparison of oral and local administration of flurbiprofen: A Clinical study in patients with ligament injuries |
| Date of disclosure of the study information | 2015/05/03 |
| Last modified on | 2015/05/03 08:48:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pharmacokinetic comparison of oral and local administration of flurbiprofen: A Clinical study in patients with ligament injuries
Acronym
Pharmacokinetic comparison of oral and local administration of flurbiprofen
Scientific Title
Pharmacokinetic comparison of oral and local administration of flurbiprofen: A Clinical study in patients with ligament injuries
Scientific Title:Acronym
Pharmacokinetic comparison of oral and local administration of flurbiprofen
Region
| Japan |
Condition
Condition
anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to compare the flurbiprofen concentration in the fat, tendon, muscle, periosteum and bone tissues as well as the plasma between topical application and oral administration.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Tissue concentrations of flurbiprofen after topical application and oral administration of flurbiprofen
Key secondary outcomes
Laboratory evaluation of blood and urine samples before and after flurbiprofen administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Two tapes (Zepolas Tape, Mikasa Seiyaku, Tokyo, Japan) are patched on the medial and lateral aspects of the knee, respectively, at 14h before sampling. Then, at 2h before sampling, the two tapes are removed, and new two tapes are patched in the same manner.
Interventions/Control_2
A tablet (Froben Tablet 40, Kaken Seiyaku, Tokyo, Japan) is orally administered in the fed state at 14h before sampling, and then, another one tablet is orally administered in the fasting state at 2h before sampling.
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
(1) patients older than 20 years, (2) patients who are scheduled to undergo primary anterior cruciate ligament reconstruction, (3) patients who are voluntarily agreed to participate in research and have a signed informed consent document.
Key exclusion criteria
(1) patients who had received any flurbiprofen or ketoprofen preparation within 2 weeks before the start of the study, (2) patients who had received an injection of a steroid, sodium hyaluronate, etc, into the affected joint within 1 week before the start of the study, (3) patients with wounds or diseases in the skin around the knee, (4) patients with a history of hypersensitivity to a certain drug, (5) patients suffering from a peptic ulcer, (6) patients with severe underlying internal diseases (heart disease, renal disease, coronary artery disease, hematological disease, etc.) or history of such diseases, (7) patients with a history of hypersensitivity to a certain NSAID, (8) patients with a history of asthma due to hypersensitivity to aspirin, (9) pregnant or possibly pregnant women or nursing women and (10) other patients judged, for any reason, to be unsuitable for the study by the attending physician.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Yasuda |
Organization
Hokkaido University Hospital
Division name
Department of Sports Medicine
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-7211
yasukaz@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Yasuda |
Organization
Hokkaido University Hospital
Division name
Department of Sports Medicine
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-7211
Homepage URL
yasukaz@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Reconstructive Surgery and Rehabilitation Medicine, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding 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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.huhp.hokudai.ac.jp/hotnews/category/112.html
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
| 2009 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020179
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
