UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048210 |
|---|---|
| Receipt number | R000054939 |
| Scientific Title | Outcome of diltiazem ointment in patients with chronic anal fissure |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/07/05 14:23:47 |
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Basic information
Public title
Outcome of diltiazem ointment in patients with chronic anal fissure
Acronym
Outcome of diltiazem ointment in patients with chronic anal fissure
Scientific Title
Outcome of diltiazem ointment in patients with chronic anal fissure
Scientific Title:Acronym
Outcome of diltiazem ointment in patients with chronic anal fissure
Region
| Japan |
Condition
Condition
chronic anal fissure
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the outcome of diltiazem ointment in patients with chronic anal fissure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of topical diltiazem use for 6weeks in patients with chronic anal fissure.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diltiazem ointment is used twice a day for at least 6 weeks
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who suffer from anal fissure for at least 2 months
Key exclusion criteria
IBD
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira Tsunoda |
| Middle name | |
| Last name | Male |
Organization
Kameda Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
2968602
Address
929 Higashi-cho, Kamogawa City, Chiba, Japan
TEL
0470922211
tsunoda.akira@kameda.jp
Public contact
Name of contact person
| 1st name | Akira Tsunoda |
| Middle name | |
| Last name | Male |
Organization
Kameda Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
2968602
Address
929 Higashi-cho, Kamogawa City, Chiba, Japan
TEL
0470922211
Homepage URL
tsunoda.akira@kameda.jp
Sponsor or person
Institute
Clinical Director, Kameda General Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical Director, Kameda General Hospital
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
Ethical Committee of Kameda Medical Center
Address
929 Higashi-cho, Kamogawa City, Chiba, Japan
Tel
0470922211
tsunoda.akira@kameda.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Journal of Japan Society of Coloproctology
Publication of results
Unpublished
Result
URL related to results and publications
ttps://www.jstage.jst.go.jp/.../76/2/76_146/_pdf/-char/en
Number of participants that the trial has enrolled
203
Results
The efficacy rate of topical diltiazem in the treatment of chronic fissure was 71% (118/167). As for adverse effects of topical diltiazem, anal itching was reported in 18% (33/182) and headache in under 1% (1/182).
Results date posted
| 2023 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between January 2014 and February 2022, a total of 203 patients with chronic anal fissure were treated with
diltiazem ointment.
Participant flow
Patients were advised to apply 2% diltiazem ointment twice a day
Adverse events
As for adverse effects of topical diltiazem, anal itching was reported in 18% (33/182) and headache in under 1% (1/182).
Outcome measures
Efficacy of topical diltiazem gel.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054939
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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