UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005385 |
|---|---|
| Receipt number | R000006367 |
| Scientific Title | The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution) |
| Date of disclosure of the study information | 2011/05/11 |
| Last modified on | 2013/10/05 09:12:28 |
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Basic information
Public title
The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)
Acronym
The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)
Scientific Title
The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)
Scientific Title:Acronym
The comparison of the clinical utility between two kinds of bowel preparations (NaP Tablets and PEG salt solution)
Region
| Japan |
Condition
Condition
The patients who need colonoscopy
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the clinical utility (colon cleansing) and the tolerability of new residue-free NaP tablets (Visiclear) compared with those of PEG solution (Niflec) in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The quality of overall colon cleansing.
Key secondary outcomes
1. The quality of colon cleansing in each 6 lesion of colon (ileocecal lesion, ascending colon, transverse colon, descending colon, sigmoid colon and rectum).
2. The amount of time to reach the cecum
3. The success rate of reaching the cecum
4. The defecation condition and the patients tolerance (by questionnaire)
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
dosage:Sodium picosulfate hydrate is taken at 9 p.m. on the previous day of colonoscopy. 50 NaP tablets are taken 5 at a time every 15 minutes with about 200 ml of clear liquids, starting 4 to 6 hours before colonoscopy. 6 Dimethicone tablets with 100ml of clear liquids are taken after 25 NaP tablets are taken.
Interventions/Control_2
dosage:Sodium picosulfate hydrate is taken at 9 p.m. on the previous day of colonoscopy. 2 to 4 L of PEG solution is taken at a speed of 1 L per hour till feces become clear liquid, starting 4 to 6 hours before colonoscopy. 6 dimethicone tablets with 100 ml of clear liquids are taken after 25 NaP tablets are taken.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who need colonoscopy irrespective of sex, inpatients or outpatients.
2. Those who submit written informed consent.
Key exclusion criteria
A. Those who are true of contraindication to NaP or PEG solution: 1. patients with congestive heart failure or unstable angina, 2. patients with long QT syndrome or critical ventricular arrhythmia, 3. patients with ascites, 4. patients with or suspected of ileus, 5. patients with or suspected of bowel perforation, 6. patients with toxic megacolon, 7. patients with critical renal failure including hemodialysis patients and patients with acute phosphate nephropathy and 8. patients with a history of hypersensitivity of NaP or PEG solution.
(As to PEG solution only 4, 5 and 6 are true of contraindication.)
B. Those who are under 20 years old or 75 years old or more, or those who are 65 years old or more taking medicine which affect renal blood flow or function (such as diuretic, angiotensin-converting enzyme inhibitor, angiotensin-receptor antagonist, NSAIDs ).
C. Those who are severely constipated (those who habitually take purgative or those who have less than 3 bowel movements a week).
D. Those who have had their digestive tract operated (except a history of appendicitis operation)
E. Those women who are pregnant, breast-feeding, or suspected of being pregnant.
F. In addition, those who are judged to be inappropriate by doctors.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Tsuji |
Organization
NTT Medical Center Tokyo
Division name
gastroenterology division
Zip code
Address
5-9-22, Higashi-Gotanda, Shinagawa-ku
TEL
03-3448-6111
ytsuji-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Tsuji |
Organization
NTT Medical Center Tokyo
Division name
gastroenterology division
Zip code
Address
5-9-22, Higashi-Gotanda, Shinagawa-ku
TEL
03-3448-6111
Homepage URL
ytsuji-tky@umin.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo, Gastroenterology Division
Institute
Department
Personal name
Funding Source
Organization
None
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
NTT東日本関東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 11 | 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
| 2011 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 05 | Day |
Last modified on
| 2013 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006367
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