Elobixibat for Chronic Constipation Without Defecation Desire (R-LODD)

  • STATUS
    Recruiting
  • End date
    Mar 14, 2023
  • participants needed
    40
  • sponsor
    Yokohama City University
Updated on 14 April 2022

Summary

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.

Details
Condition Chronic Constipation
Treatment Elobixibat 10mg
Clinical Study IdentifierNCT05165199
SponsorYokohama City University
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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