UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040416 |
|---|---|
| Receipt number | R000045766 |
| Scientific Title | Comparison of 1L PEG plus ascorbic acid with Linaclotide versus Sennoside for colon cleaning in constipated patients: A single blind, randomized controlled clinical trial. |
| Date of disclosure of the study information | 2020/05/18 |
| Last modified on | 2022/05/26 10:19:47 |
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Basic information
Public title
Comparison of 1L PEG plus ascorbic acid with Linaclotide versus Sennoside for colon cleaning in constipated patients: A single blind, randomized controlled clinical trial.
Acronym
Efficacy of Linaclotide as an adjuvant for bowel preparation in constipated patients: A single blind, randomized controlled clinical trial.
Scientific Title
Comparison of 1L PEG plus ascorbic acid with Linaclotide versus Sennoside for colon cleaning in constipated patients: A single blind, randomized controlled clinical trial.
Scientific Title:Acronym
Efficacy of Linaclotide as an adjuvant for bowel preparation in constipated patients: A single blind, randomized controlled clinical trial.
Region
| Japan |
Condition
Condition
Constipated outpatients who were scheduled colonoscopy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess adequacy and tolerability of 1 L polyethylene glycol plus ascorbic acid with Linaclotide versus Sennoside.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of preparation adequacy and an overall colon cleansing score of 6 or more using Boston bowel preparation scale.
Key secondary outcomes
Boston bowel preparation scale score
Side effects or complications
Quality of sleep
Willingness to repeat the procedure
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We use 0.5 mg of Linaclotide as an adjuvant for bowel preparation on the day prior to the procedure
Interventions/Control_2
We use 24 mg of Sennoside as an adjuvant for bowel preparation on the day prior to the procedure
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Constipated outpatients who were scheduled
colonoscopy. Chronic constipation was diagnosed by Rome 4 criteria.
Key exclusion criteria
1)contraindication to bowel preparation (congestive heart failure, renal insufficiency, liver failure, a life-threatening condition)
2)mechanical bowel obstruction
3)history of colectomy
4)current pregnancy/lactating
5)active inflammatory bowel disease
6)refusal to provide consent
Target sample size
526
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fukuda |
Organization
Minamiosaka Hospital
Division name
Department of Gastroenterology
Zip code
559-0012
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka Japan
TEL
0666850221
t.fukuda@minamiosaka.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Higashimori |
Organization
Osaka City University Graduate school of Medicine
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka Japan
TEL
0666453811
Homepage URL
higamo@med.osaka-cu.ac.jp
Sponsor or person
Institute
Minamiosaka Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Minamiosaka Hospital
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka Japan
Tel
0666850221
higamo@med.osaka-cu.ac.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
| 2020 | Year | 05 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2020 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045766
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
