UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029418 |
|---|---|
| Receipt number | R000017972 |
| Scientific Title | Exporatory clinical study for newly developed drug therapy for preeclampsia with oral nicotinamide |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2023/10/09 09:46:23 |
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Basic information
Public title
Exporatory clinical study for newly developed drug therapy for preeclampsia with oral nicotinamide
Acronym
Exporatory clinical study for preeclampsia with oral nicotinamide
Scientific Title
Exporatory clinical study for newly developed drug therapy for preeclampsia with oral nicotinamide
Scientific Title:Acronym
Exporatory clinical study for preeclampsia with oral nicotinamide
Region
| Japan |
Condition
Condition
preeclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of oral nicotinamide for preeclamptic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prolongation of gestational period
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
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nicotinamide:400mg/day until delivery
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1)preeclampsia;
diagnosed after preganancy 20wks with
BP>=140/90
Protein uria>=300mg/day
2)clinical limitations;
chronic hypertension
renal dysfunction (creatinine>=1.5mg/dl)
vascular disease, SLE, DM
hepatitis
cerebrovascular disorder
3)clinical examination value;
AST, ALT<=105 IU/L
Creatinine<=1.5mg/dl
Platelet>=100,000
4)written informed consent
Key exclusion criteria
1)pulmonary edema
2)HELLP syndrome
3)non reasuring fetal status
4)estimated fetal body weight<1.5SD
oligohydramnios: maximum vertical pocket<2cm
intermittent or retrograde umbilical blood flow
5)genital bleeding of unknown origin
6)progression of premature labor
7)allegey for nicotinamide
8)dangerous situations for mother or fetus evaluated by doctors
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sugawara |
Organization
Tohoku University graduate School of medicine
Division name
division of feto-maternal medical science
Zip code
980-8573
Address
2-1 Seiryocho, Aoba-ku, Sendai
TEL
022-273-6283
jsugawara@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Sugawara |
Organization
Tohoku University graduate School of medicine
Division name
division of feto-maternal medical science
Zip code
980-8573
Address
2-1 Seiryocho, Aoba-ku, Sendai
TEL
022-273-6283
Homepage URL
jsugawara@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tohoku Certified Review Board of Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
東北大学病院 Tohoku University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 04 | 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 | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017972
| 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 |
