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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035794
Receipt No. R000040776
Scientific Title A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation
Date of disclosure of the study information 2019/02/13
Last modified on 2019/08/08

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Basic information
Public title A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation
Acronym A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation
Scientific Title A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation
Scientific Title:Acronym A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation
Region
Japan

Condition
Condition Chronic constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the actual clinical features of chronic constipation. To evaluate the efficacy of therapeutic drugs on chronic constipation. To validate the newly developed questionnaire for chronic constipation, the Chronic Constipation-Therapeutic Efficacy and Satisfaction Test (CC-TEST).
Basic objectives2 Others
Basic objectives -Others To study the effect of each constipation symptoms on patients' dairy life. To compare the efficacy of therapeutic drugs on chronic constipation among the groups divided by their mechanism of action. To examine the relationship between the patients' background factors and the clinical features of chronic constipation.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The actual clinical features of chronic constipation explored by several questionnaires such as CC-TEST, Constipation Scoring System (CSS), Hospital Anxiety and Depression Scale (HADS), and Short Form-8 (SF-8). The efficacy of the therapeutic drugs on chronic constipation. The reliability and validity of the newly developed questionnaire for chronic constipation, CC-TEST. Outcome measures evaluation using questionnaires were performed at baseline, at 2 weeks and at 4 weeks after medication.
Key secondary outcomes The effect of each constipation symptoms on patients' dairy life. Comparison of the efficacy of therapeutic drugs on chronic constipation among the groups divided by their mechanism of action. The relationship between the patients' background factors and the clinical features of chronic constipation.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Moderate or severe chronic constipation
(2) Age over 20 years old, any sex
(3) Spontaneous agreement of the said person
(4) Capable to understand the questionnaire
Key exclusion criteria (1) Alarm feature such as vomiting, gastrointestinal tract bleeding, (includes hematemesis, bloody stool, anemia, etc.) or rapid weight loss
(2) History of gastrointestinal tract resection or vagotomy
(3) Any other disease or previous surgery which may influence the results of questionnaire more than chronic constipation
(4) Any organ failure or mental disease
(5) Confirmed or suspected malignancy
(6) Pregnancy, possible pregnancy, or breastfeeding
(7) Judged as irrelevant by the responsible doctor of this study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Nakada
Organization The Jikei University Daisan Hospital
Division name Department of Laboratory Medicine
Zip code 201-8601
Address 4-11-1, Izumihoncyo, Komae-shi, Tokyo, 201-8601 Japan
TEL 03-3480-1151
Email nakada@jikei.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Nakada
Organization The Jikei University Daisan Hospital
Division name Department of Laboratory Medicine
Zip code 201-8601
Address 4-11-1, Izumihoncyo, Komae-shi, Tokyo, 201-8601 Japan
TEL 03-3480-1151
Homepage URL
Email nakada@jikei.ac.jp

Sponsor
Institute Others
Department of Laboratory Medicine, The Jikei University Daisan 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 The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Address 3-25-8, Nishishinbashi, Minato-ku, Tokyo, 105-8461 Japan
Tel 03-3433-1111
Email rinri@jikei.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 東京慈恵会医科大学附属第三病院(東京都)、一志胃腸科クリニック(東京都)、川崎医科大学附属病院(岡山県)、東京慈恵会医科大学附属病院(東京都)、東京慈恵会医科大学葛飾医療センター(東京都)、東邦大学医療センター大森病院(東京都)、愛知医科大学病院(愛知県)、九州大学医学部附属病院(福岡県)、平和台クリニック(東京都)、秋田大学医学部附属病院(秋田県)、日本医科大学付属病院(東京都)、順天堂大学医学部附属順天堂医院 (東京都)、やまもと消化器内科クリニック(東京都)、羽田バス通りクリニック(東京都)、名古屋市立大学病院(愛知県)、内山胃腸科(東京都)、横浜市立大学附属病院(神奈川県)、群馬大学医学部附属病院(群馬県)、京都府立医科大学附属病院(京都府)、大阪医科大学附属病院(大阪府)、鳥居内科クリニック(東京都)、NTT東日本関東病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 13 Day
Date of IRB
2019 Year 04 Month 08 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2021 Year 02 Month 27 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 04 Month 30 Day
Date analysis concluded
2021 Year 06 Month 30 Day

Other
Other related information Multicenter prospective observational study
(1) Chronic Constipation-Therapeutic efficacy and Satisfaction Test (CC-TEST)
(2) Constipation Scoring System (CSS)
(3) Hospital Anxiety and Depression Scale (HADS)
(4) Short Form-8 (SF-8)
(5) Administered therapeutic drugs for chronic constipation during observation period
(6) Severity of chronic constipation
(7) Age
(8) Sex
(9) Height
(10) Body weight
(11) Activities of Daily Living (ADL)
(12) Illness period
(13) Consultation history of medical institution due to chronic constipation
(14) Coping or treatment for chronic constipation during the past month
(Food or Beverage / Supplement / Over-the-counter drugs / Prescription drugs
(15) History of abdominal surgery or Delivery
(16) Causal comorbidity of chronic constipation
(17) Causal prescription drugs of chronic constipation
And so on.

Management information
Registered date
2019 Year 02 Month 06 Day
Last modified on
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040776

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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