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| Name | Class |
|---|---|
| Cato Research | INDUSTRY |
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The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo TID |
|
| DAIKENCHUTO (TU-100) 15 g/day | Experimental | TU-100 5g TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAIKENCHUTO (TU-100) | Drug | Subjects will be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 28 in CSI total score | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in GI transit time measured by SmartPill capsule. | Up to 10 weeks | |
| Change from baseline to Day 28 in CRQOL total score. | Up to 10 weeks | |
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Inclusion Criteria:
Have severity of constipation in CSI score of 25 to 74 points.
Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
Be male or female aged between 18 and 80 years old, inclusive.
Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
If a female is of childbearing potential and sexually active:
If a male is sexually active with a female of childbearing potential:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders F Mellgren, MD, PhD | Colon and Rectal Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colon and Rectal Surgery Associates | Minneapolis | Minnesota | 55407 | United States |
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| ID | Term |
|---|---|
| C121414 | dai-kenchu-to |
| C559645 | 12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine |
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| Placebo | Drug | Subjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days. |
|
| Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary. |
| Up to 10 weeks |
| Change from baseline to Day 28 in CSI subscale scores. | Up to 10 weeks |
| Change from baseline to Day 28 in CRQOL subscale scores. | Up to 10 weeks |