UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015796 |
|---|---|
| Receipt number | R000018383 |
| Scientific Title | Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/01/06 11:19:35 |
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Basic information
Public title
Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea
Acronym
Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea
Scientific Title
Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea
Scientific Title:Acronym
Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea
Region
| Japan |
Condition
Condition
Dysmenorrhea
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness against dysmenorrhea of tranilast in placebo-controlled
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
VAS of dysmenorrhea
Key secondary outcomes
Dysmenorrhea score
Lower abdominal pain during menstruation, low back pain, headache, degree of nausea
Other than during menstruation pelvic pain VAS
Serum CA125 concentration
TTF (Time to Treatment Failure)
(such as incidence of adverse events)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tranilast administration of between 6 months
Interventions/Control_2
placebo administration of between 6 months
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) age is less than 45 years of age or 20 years of age at the time of obtaining informed consent, menstrual cycle is 25-38 days patients
(2) patients with dysmenorrhea VAS is greater than or equal to 30mm
(3) patients symptoms of dysmenorrhea has been controlled by only the use of N-saids, which has been determined to be controlled by only N-Saids throughout the study period
(4) patients who do not wish to become pregnant during the study period
(5) for participation in the study, patients consent document person was obtained
Key exclusion criteria
(1) age is less than 45 years of age or 20 years of age at the time of obtaining informed consent, menstrual cycle is 25-38 days patients
(2) patients with dysmenorrhea VAS is greater than or equal to 30mm
(3) patients symptoms of dysmenorrhea has been controlled by only the use of N-saids, which has been determined to be controlled by only N-Saids throughout the study period
(4) patients who do not wish to become pregnant during the study period
(5) for participation in the study, patients consent document person was obtained
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetaka Katabuchi |
Organization
Kumamoto University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5269
buchi@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ritsuo Honda |
Organization
Kumamoto University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5269
Homepage URL
ritz@kumamoto-u.ac.jp
Sponsor or person
Institute
Endometriosis / Tranilast Study Group
Institute
Department
Personal name
Funding Source
Organization
ASKA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018383
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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