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In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elobixibat | Experimental | AJG533 (elobixibat) 10 mg orally once a day before meals for 12 weeks |
|
| Placebo | Placebo Comparator | AJG533 placebo orally once a day before meals for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elobixibat 10mg | Drug | Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of complete spontaneous bowel movements at week 12 | Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. *Spontaneous defecation without residual sensation. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of complete spontaneous bowel movements in each week of the treatment period. | Change in the number of complete spontaneous bowel movements in each week of the treatment period. | Each Week 1-11 |
| Change in the number of spontaneous bowel movements in each week of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events. | Incidence of adverse events. | Each Week 1-11 |
Inclusion Criteria:
At the time of allocation (dosing initiation criteria)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takaomi Kessoku, M.D., PhD. | Contact | +81-45-787-2800 | 2640 | kessoku-tho@umin.ac.jp |
| Atsushi Nakajima, M.D., PhD. | Contact | +81-45-787-2800 | 2640 | nakajima-tky@umin.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Takaomi Kessoku, M.D., PhD. | Yokohama City University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama City University | Recruiting | Yokohama | Kanagawa | 236-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29805116 | Background | Nakajima A, Seki M, Taniguchi S, Ohta A, Gillberg PG, Mattsson JP, Camilleri M. Safety and efficacy of elobixibat for chronic constipation: results from a randomised, double-blind, placebo-controlled, phase 3 trial and an open-label, single-arm, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):537-547. doi: 10.1016/S2468-1253(18)30123-7. Epub 2018 May 25. | |
| 35636802 |
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| ID | Term |
|---|---|
| C581303 | elobixibat |
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| Placebo | Drug | Patients with chronic constipation are administered placebo for 12 weeks |
|
|
Change in the number of spontaneous bowel movements in each week of the treatment. |
| Each Week 1-11 |
| Proportion of responders** in the number of SBMs during each week. | Proportion of responders** in the number of spontaneous bowel movements (SBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of SBMs of a subject who has at least one more SBM per week than in the second week of the observation period, and at least three times per week. | Each Week 1-11 |
| Proportion of responders** in the number of CSBMs during each week. | Proportion of responders** in the number of complete spontaneous a bowel movements (CSBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of CSBMs of a subject who has at least one more CSBMs per week than in the second week of the observation period, and at least three times per week. | Each Week 1-11 |
| The rate of a responder in the number of CSBM during the treatment period. | Definition of Responder: Patients with 3 or more CSBM per week and 1 or more CSBM per week from baseline for 9 weeks out of the entire treatment period (12 weeks), including at least 3 weeks in the treatment period weeks 9 to 12. | Week 12 |
| Percent change in fecal hardness based on the Bristol Stool Quality Scale at each week. | Percent change in fecal hardness from week 2 of the observation period based on the Bristol Stool Quality Scale at each week of the treatment period. the minimum is 1 and maximum values, is 7.Higher scores mean a better outcome. | Each Week 1-11 |
| The percentage of change in the presence or absence of residual sensation at each week. | The percentage of change from week 2 of the observation period in the presence or absence of residual sensation at each week of the treatment period. | Each Week 1-11 |
| Percent change in the degree of twitching at each week. | Percent change from week 2 of the observation period in the degree of twitching at each week of the treatment period. | Each Week 1-11 |
| The percentage of change in the presence or absence of bowel movements at each week. | The percentage of change in the presence or absence of bowel movements at each week of the treatment period from week 2 of the observation period. | Each Week 1-11 |
| Change in Japanese Patient assessment of constipation quality of life score | Change in Japanese Patient assessment of constipation quality of life score at 4 and 12 weeks of the treatment period from the baseline (V2) of the study drug.the minimum is 0 and maximum values is 4.Lower scores mean a better outcome. | Week 4, 12 |
| The changes in occupancy rate of intestinal microbiota. | At 4 weeks and 12 weeks of the treatment period, the changes in occupancy rate of intestinal microbiota in feces from before the start of the study drug (V2) are examined. | Week 4, 12 |
| The change in absolute values rates in blood and fecal bile acids. | At 4 weeks and 12 weeks of the treatment period, the change in absolute values in blood and fecal bile acids from before the start of the study drug (V2) are examined. | Week 4, 12 |
| The change in absolute values for organic acids. | At 4 weeks and 12 weeks of the treatment period, the change in absolute values for organic acids in feces from before the start of the study drug (V2) are examined. | Week 4, 12 |
| The change in absolute values of amino acids in blood and feces. | At 4 weeks and 12 weeks of the treatment period, the change in absolute values of amino acids in blood and feces. from before the start of the study drug (V2) are examined. | Week 4, 12 |
| The change in amount blood C4. | At 4 weeks and 12 weeks of the treatment period, the change in amount blood C4 from before the start of the study drug (V2) are examined. | Week 4, 12 |
| Tanaka K, Kessoku T, Yamamoto A, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Kato T, Arimoto J, Fuyuki A, Sakai E, Higurashi T, Chiba H, Hosono K, Yoneda M, Iwasaki T, Kurihashi T, Nakatogawa M, Suzuki A, Taguri M, Oyamada S, Ariyoshi K, Kobayashi N, Ichikawa Y, Nakajima A. Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation. BMJ Open. 2022 May 30;12(5):e060704. doi: 10.1136/bmjopen-2021-060704. |