UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040778 |
|---|---|
| Receipt number | R000046567 |
| Scientific Title | Therapeutic intervension for post-craniotomy headache |
| Date of disclosure of the study information | 2020/06/16 |
| Last modified on | 2023/12/19 16:55:35 |
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Basic information
Public title
Therapeutic intervension for post-craniotomy headache
Acronym
Therapeutic intervension for post-craniotomy headache
Scientific Title
Therapeutic intervension for post-craniotomy headache
Scientific Title:Acronym
Therapeutic intervension for post-craniotomy headache
Region
| Japan |
Condition
Condition
post-craniotomy headache
Classification by specialty
| Neurosurgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pathophysiology of post-craniotomy headache has not been known. There is no clinically established therapy for post-craniotomy headache. We will investigate clinical effect of neurotropine for post-craniotomy headache.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
frequency and intensity of post-craniotomy headache at 1 and 3 months after neurotropine intake
Key secondary outcomes
Patient factor(primary disease, age, sex)
Post-craniotomy headache(occurence period, frequency, intensity)
Craniotomy(surgery, skin incision, dural closure, craniectomy, cranioplasty)
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prescription of Neurotropine 4T x2
From the occurence of post-craniotomy headache to the remission.
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
| 6 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Post-craniotomy headache
Key exclusion criteria
Chronic headache case.
Post-craniotomy complication case.
The patient who could not evaluate their headache because of consciousness disturbance or dysphagia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba
Division name
Neurosurgery
Zip code
3100015
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
TEL
+81292312371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba
Division name
Neurosurgery
Zip code
3100015
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
TEL
+81292312371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Miyamachi 3-2-7, Mito, Ibaraki, Japan
Tel
+81292312371
yshibata@md.tsukuba.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
筑波大学 水戸地域医療教育センター【茨城県】
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
pending
Publication of results
Unpublished
Result
URL related to results and publications
pending
Number of participants that the trial has enrolled
100
Results
pending
Results date posted
| 2023 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
pending
Participant flow
pending
Adverse events
no
Outcome measures
pending
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046567
| 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 |
