UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023481 |
|---|---|
| Receipt number | R000026673 |
| Scientific Title | The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial |
| Date of disclosure of the study information | 2016/08/04 |
| Last modified on | 2020/02/14 13:20:13 |
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Basic information
Public title
The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial
Acronym
The effectivity of nifedipine ointment for anal fissures
Scientific Title
The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial
Scientific Title:Acronym
The effectivity of nifedipine ointment for anal fissures
Region
| Japan |
Condition
Condition
anal fissure
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to demonstrate the efficacy and the safety of the nifedipine ointment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of improvement of the pain from the anal fissure after the use of the nifedipine ointment
Key secondary outcomes
the change of the maximum anal resting pressure and squeezing pressure bfore and after the therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients put the nifedipine ointment on their anal verges once a day for 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.over the age of twenty
2.the patients suffering from the pain or bleeding for the anal fissures
3.the patients suffering from the persisting pain despite of traditional treatments
4.the patients obtained the informed consent
Key exclusion criteria
1.the patients who are unable to put the ointment to their anal verges
2.the patients who have the physical stenosis requiring surgical intervention
3.the patients who have the severe cardiovascular, blood, respiratory, neuropsychiatric, autimmune diseases
4.pregnancy or lactating women
5.the patients found inadequate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Aikawa |
Organization
Matsuda hospital
Division name
colo-proctology department
Zip code
4328061
Address
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
TEL
053-448-5121
aiko-a@matsuda-hp.or.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Aikawa |
Organization
Matsuda hospital
Division name
colo-proctology department
Zip code
4328061
Address
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
TEL
053-448-5121
Homepage URL
aiko-a@matsuda-hp.or.jp
Sponsor or person
Institute
Matsuda hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuda hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsuda Hospial
Address
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
Tel
0534485121
crc@matsuda-hp.or.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
松田病院 （静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi.org/10.3862/jcoloproctology.72.53
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3862/jcoloproctology.72.53
Number of participants that the trial has enrolled
32
Results
Change of face scale (FS)
FS at defecation and resting significantly decreased. (p<0.001)
Effective group and invalidity group
The invalid cases were common in men.
As for the invalid cses, MRP were significantly high level.
Results date posted
| 2020 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We intended for the 40 patients(20 years or older) with anal fissure which is not improved by conservative treatment.
Participant flow
We applied nifedipine ointment to anal verge with a cotton swb or a finger once a day.
Adverse events
One patient had a headache and it was effective, but canceled use.
Outcome measures
We evaluated pain in FS(face scale) before treatment and 2 weeks later, 1,2,3 months later.
We evaluated MRP(maximum resting pressure) before treatment and 1,3 months later.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026673
