UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035794 |
|---|---|
| Receipt number | 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 | 2023/02/09 12:43:27 |
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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
800
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
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
nakada@jikei.ac.jp
Sponsor or person
Institute
Others
Department of Laboratory Medicine, The Jikei University Daisan Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Jikei University School of Medicine
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
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）、帝京大学医学部附属病院（東京都）、ときとうクリニック（埼玉県）、日本医大武蔵小杉病院（神奈川県）、兵庫医科大学病院（兵庫県）、川村病院（静岡県）、渡辺胃腸科外科病院（岡山県）
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
Completed
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
| 2022 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | 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
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040776
