Chronic constipation
Conditions
Interventions
Sponsors
International university health and welfare Narita hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria At the time of provisional registration Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation Age 20 years or older (at the time of obtaining consent) Gender Any outpatients Patients for whom written consent can be obtained Patients who can record defecation, etc. in the patient diary At the time of registration Dosing start criteria Patients with the following Loss of defecation desire in the second week of the observation period (1 week before the start of the treatment period) Loss of defecation desire refers to patients whose presence or absence of defecation desire on the patient questionnaire was 4. almost never or 5. never.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: At the time of temporary registration Exclude patients with any of the following conditions Patients with organ-related constipation or suspected of having organ-related constipation Patients with or suspected of having functional ileus Patients with or suspected of having inguinal hernia Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection) Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered. Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study Patients with serious renal, hepatic, or cardiac disease Patients with drug allergy to the study drug Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded. Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study. At the time of registration: Dosing start criteria Patients who increased the dose of concomitantly restricted drugs during the observation period Patients who used concomitantly prohibited drugs during the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of change in loss of defecation desire | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following items during each week of the treatment period and comparison of the fourth week of the treatment period with the second week of the observation period 1 Presence of defecation desire 2 Satisfaction with defecation desire 3 Satisfaction of straining 4 Degree of straining 5 Presence of a sense of incomplete evacuation 6 Satisfaction with treatment 7 Spontaneous bowel movement (SBM) frequency 8 Complete Spontaneous Bowel Movement (CSBM) frequency 9 Stool hardness based on the Bristol Stool Form Scale Comparison of Week 4 of the treatment period with Week 2 of the observation period 1 Constipation severity score (CSS) 2 Japanese version of the Patient Assessment of Constipation Quality of Life 3 Change of bile acid cocentration Change in defecation time. Examine the relevance among the evaluation items To examine the relationship among endpoints such as improvement in defecation desire, patient satisfaction, and bile acid levels. Safety assessment Incidence rate of diseases | — |
Countries
Japan
Contacts
Public ContactTakaomi Kessoku
International university health and welfare Narita hospital Palliative medicine and Gastroenterology
Outcome results
None listed