UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013266 |
|---|---|
| Receipt number | R000012411 |
| Scientific Title | Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy |
| Date of disclosure of the study information | 2014/02/25 |
| Last modified on | 2014/02/25 15:49:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy
Acronym
Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy
Scientific Title
Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy
Scientific Title:Acronym
Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy
Region
| Japan |
Condition
Condition
ulcerative colitis, familial adenomatous polyposis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and comparison 1% of Dermacrin A ointment with 0.033% of Guaiazulene ointment after total colectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Grade of dermatitis at Week 2 and Week 4
Key secondary outcomes
Relation between pH of the stool and Grade of dermatitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1% of Dermacrin A ointment
Interventions/Control_2
0.033% of Guaiazulene ointment
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)patients with ulcerative colitis or familial adenomatous polyposis after total colectomy
2)patients from whom informed consent was obtained
Key exclusion criteria
1)history of hypersensitivity to treatment agent
2)patients judged to be unsuitable for this trial
3)patients under the age of 20 or with psychiatric disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Araki |
Organization
Mie University Graduate School of Medicine
Division name
Gastrointestinal and Pediatric Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5294
taraki@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Araki |
Organization
Mie University Graduate School of Medicine
Division name
Gastrointestinal and Pediatric Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5294
Homepage URL
taraki@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery
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
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 | 02 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012411
