UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023481
Receipt No. 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 (Ver. 6)

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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
Email 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
Email aiko-a@matsuda-hp.or.jp

Sponsor
Institute Matsuda hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026673