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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elobixibat | Experimental | 10mg Elobixibat administration for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elobixibat 10mg | Drug | Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change in loss of defecation desire | Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of defecation desire | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of diseases | Safety assessment | Week 0-4 |
Inclusion Criteria:
At the time of provisional registration
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
At the time of registration、Dosing start criteria
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| Name | Affiliation | Role |
|---|---|---|
| Takaomi Kessoku, M.D., PhD. | International university health and welfare Narita hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International university health and welfare Narita hospital | Narita | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32858571 | Background | Ohkubo H, Takatsu T, Yoshihara T, Misawa N, Ashikari K, Fuyuki A, Matsuura T, Higurashi T, Yamamoto K, Matsumoto H, Odaka T, Lembo AJ, Nakajima A. Difference in Defecation Desire Between Patients With and Without Chronic Constipation: A Large-Scale Internet Survey. Clin Transl Gastroenterol. 2020 Sep;11(9):e00230. doi: 10.14309/ctg.0000000000000230. |
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| ID | Term |
|---|---|
| C581303 | elobixibat |
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| Satisfaction with defecation desire | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Satisfaction of straining | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire). | Week 4 |
| Degree of straining | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire). | Week 4 |
| Presence of a sense of incomplete evacuation | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Satisfaction with treatment | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Spontaneous bowel movement (SBM) frequency | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily). | Week 4 |
| Complete Spontaneous Bowel Movement (CSBM) frequency | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily). | Week 4 |
| Stool hardness based on the Bristol Stool Form Scale | Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Constipation severity score | Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Japanese version of the Patient Assessment of Constipation Quality of Life | Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionraire at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). | Week 4 |
| Change of bile acid concentration | Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces). | Week 4 |
| Change in defecation time. | Changes in the time from taking elobixibat to defecation each week during the treatment period | Week 4 |