UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013892 |
|---|---|
| Receipt number | R000014509 |
| Scientific Title | A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2014/05/06 |
| Last modified on | 2014/05/06 15:52:41 |
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Basic information
Public title
A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy
Acronym
AJG522 versus PEG plus E for colonoscopy
Scientific Title
A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy
Scientific Title:Acronym
AJG522 versus PEG plus E for colonoscopy
Region
| Japan |
Condition
Condition
Ulcerative colitis and so on
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, safety, and acceptability of the AJG522 preparation compared to a standard PEG+E preparation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The fecal properties as a bowel cleansing condition for the colonoscopy via the macroscopic observation of stool.
Key secondary outcomes
Taste, acceptability, willingness to repeat, patient satisfaction, and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
AJG522
Interventions/Control_2
PEG plus E (Niflec®)
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)Inpatients who are scheduled to receive colonoscopy.
2)consenting study subjects.
2)written informed consent was achieved.
Key exclusion criteria
Subjects had any of the following: a history of colonic resection; ileus; gastrointestinal obstruction or perforation; severe inflammatory bowel disease, such as toxic megacolon; heart failure (New York Heart Association [NYHA] Class III or IV); acute life-threatening cardiovascular disease; untreated or uncontrolled hypertension; severe liver failure; severe psychosomatic disease; or end-stage renal insufficiency. Hospitalized patients
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Sagawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8137
m07702015@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Sagawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8137
Homepage URL
m07702015@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc., Tokyo, Japan.
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
群馬大学医学部付属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 06 | 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
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | 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
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2014 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014509
