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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TU-100 | Experimental | 15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily) |
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| Matching placebo | Placebo Comparator | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TU-100 | Drug | 15g daily, orally as 5g three times daily for 4 consecutive weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Abdominal bloating rating | Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for abdominal bloating ratings using lactulose challenge | Change in area under the curve (AUC) for abdominal bloating ratings obtained during the lactulose challenge at Visit 2 (baseline) and at Visit 4 (4 weeks). The data are collected at -0.5, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 hours after taking test meal (lactulose). | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Examination | Physical examination at Visits 1, 2 and 4 | 4 weeks |
| Vital Signs | 2. Vital signs (pulse, blood pressure, temperature, and respiration rate) at Visits 1, 2 and 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Tillisch, MD | Oppenheimer Family Center of Neurobiology of Stress, UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C559645 | 12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine |
| C121414 | dai-kenchu-to |
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| Placebo | Drug | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
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| Abdominal bloating ratings | Change in the average of abdominal bloating ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 (2 weeks) and to Visit 5 (8 weeks) | 4 weeks |
| Overall IBS Severity | Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5 | 4 weeks |
| GI symptom ratings | Change in the average of GI symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5 | 4 week |
| Quality of Life effect | Change in IBS-QOL score from baseline to Visits 3, 4, and 5 | 4 weeks |
| Mood symptom ratings | Change in the average of mood symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5 | 4 weeks |
| 4 weeks |
| Adverse Events and Concomitant Medications | Interview for adverse events (AEs) and concomitant medications at Visits 3, 4 and 5 | 8 weeks |
| Laboratory safety tests | Laboratory safety tests including hematology, chemistry, and urinalysis at Visits 1, 2 and 4. Pregnancy test for subjects of childbearing potential at Visits 1, 2, 3, 4 and 5. | 8 weeks |
| D004066 | Digestive System Diseases |