UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019966 |
|---|---|
| Receipt number | R000023047 |
| Scientific Title | Efficacy and safety of valproic acid in patients with postviral olfactory dysfunction |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2022/05/25 13:43:39 |
* 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
Efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Acronym
Valproic acid treatment of olfactory dysfunction
Scientific Title
Efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Scientific Title:Acronym
Valproic acid treatment of olfactory dysfunction
Region
| Japan |
Condition
Condition
postviral olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
changes of average recognition threshold scores measured by T and T olfactometer before and after treatment
Key secondary outcomes
changes of scores before and after treatment (visual analog scale and 5 grading scale of subjective symptoms, score measured by the odor stick identification test for Japanese, and average detection threshold scores measured by T and T olfactometer)
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
valproic acid Tab (200mg tablet), Sig: 1
tablet po BID for 24 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients are diagnosed to be a postviral olfactory dysfunction
2) Male patients of 20 or older and younger than 80 at the time of obtaining their consents, and Postmenopausal female patients younger than 65
3) Patients who understand the substances of this Trial and can consent in writing
Key exclusion criteria
Exclusion Criteria concerning Diagnosis
1)Patients taking Carbapenem,Barbituric acid,phenytoin, Carbamazepine, ethosuximide, amitriptyline, clobazam, lamotrigine, salicylic acid, Benzodiazepine, warfarin, erythromycin, cimetidine, clonazepam)
2) Patients having a history of serious drug allergies
3) Patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases
4) Patients with liver dysfunction
5) Patients with renal dysfunction
6) Female patients having fertility
7) Patients with urea cycle abnormality
8) Patients with past history of an encephalopathy or a coma caused by unknown
9) Patients having a family member with urea cycle abnormality or who experience infant death
10) Patients with subjective olfactory loss before onset of postviral olfactory dysfunction
11) Patients who are otherwise judged unfit as a subject for this trial by a principal investigator or investigators participating in this trial
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Kikuoka |
Organization
Shiga university of Medical Science
Division name
otorhinolaryngology
Zip code
520-2153
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2261
takao971@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Ogawa |
Organization
Shiga university of Medical Science
Division name
otorhinolaryngology
Zip code
520-2153
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2261
Homepage URL
takao971@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of otorhinolaryngology,
Shiga university of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
shiga university of medical science
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
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
| 2016 | Year | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023047
