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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040416
Receipt No. 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 2020/05/15

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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
Email 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
Email higamo@med.osaka-cu.ac.jp

Sponsor
Institute Minamiosaka Hospital
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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