UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020044 |
|---|---|
| Receipt number | R000022459 |
| Scientific Title | Tadalafil treatment for Fetus with Early onset growth Restriction |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2016/09/03 14:45:40 |
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Basic information
Public title
Tadalafil treatment for Fetus with Early onset growth Restriction
Acronym
Tadalafil treatment for Fetus with Early onset growth Restriction(TADAFER)
Scientific Title
Tadalafil treatment for Fetus with Early onset growth Restriction
Scientific Title:Acronym
Tadalafil treatment for Fetus with Early onset growth Restriction(TADAFER)
Region
| Japan |
Condition
Condition
fetal growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of tadalafil study and estimate the maximum tolerated dose, to determine the recommended dose in Phase 2 trial
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation time: until after the end of the study four weeks from the start of study
Safety of maternal and fetal
(Maternal: biochemistry, urinalysis, electrocardiogram, concentration in the drug blood
Fetus: chest abdominal X-ray, heart ultrasound examination, head ultrasound, blood drug concentration)
Key secondary outcomes
The maximum tolerated dose, the optimal dose, fetal abdominal circumference, estimated fetal weight, neonatal death, perinatal death, obstetric complications (gestational hypertension, preterm labor, placental abruption), birth weight, birth weeks, Apgar score, umbilical artery blood gas, fetal arterial blood flow test, fetal venous blood flow test, uterine artery blood flow test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks)
Dose and method: 3 cases cohort
Cohort 1: tadalafil once a day, once 10 mg <Zalutia(5 mg) 2 tablets> daily administration
Interventions/Control_2
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks)
Dose and method: 3 cases cohort
Cohort 2: tadalafil once a day, once 20 mg <Adcirca(20 mg) 1 tablet> daily administration
Interventions/Control_3
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks)
Dose and method: 3 cases cohort
Cohort 3: tadalafil once a day, once 40 mg <Adcirca(20 mg) 2 tablets> daily administration
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
Female
Key inclusion criteria
1) Fetal growth restriction (less than -1.5SD)
2) Healthy pregnancy 22 weeks after less than 34 weeks
3) Single pregnancy
4) 20 years of age or older
5) For the test participation, it has consent is obtained in writing from the patient.
Key exclusion criteria
1) Patients with allergic to tadalafil
2) Patients are taking the drug, which is contraindicated to tadalafil
3) Patients are undergoing kidney dialysis, with severe renal impairment(creatinine clearance<30mL / min)
4) Patients with severe liver failure [AST (GOT) or ALT (GPT)>100 IU / L]
5) Patients with uncontrolled arrhythmias, hypotension (blood pressure <90 / 50mmHg), or uncontrolled high blood pressure (blood pressure> 170 / 100mmHg)
6) Fetus with chromosomal abnormality can be considered from ultrasonography
7) Retinitis pigmentosa patients
8) Patients with bleeding disorders or peptic ulcer
9) Patients with pulmonary venous occlusive disease
10) Patient is determined to be unsuitable as a study subject
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ikeda |
Organization
Mie University Faculty of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
Address
2-174 Edobashi Tsu-city Mie
TEL
059-232-1111
t-ikeda@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Kubo |
Organization
Mie University Faculty of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
Address
2-174 Edobashi Tsu-city Mie
TEL
059-232-1111
Homepage URL
mkubo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics & Gynecology Mie University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics & Gynecology Mie University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
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
三重大学医学部附属病院産科婦人科(三重県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2016 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022459
