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| Name | Class |
|---|---|
| Cato Research | INDUSTRY |
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TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous decoction and granulation technology. The aim of this study is to assess the effect of TU-100 on post-operative quality of life during the 4 week postoperative period after straight, hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome studies also will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daikenchuto (TU-100) | Experimental | Daikenchuto (TU-100) 5g TID (15g/day) |
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| Placebo | Placebo Comparator | Placebo TID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daikenchuto (TU-100) | Drug | Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates. | Baseline and 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Jensen, M.D., M.P.H. | Colon & Rectal Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Site | Los Angeles | California | 90048 | United States | ||
| Aurora Site |
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The study was carried out at 16 sites in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Daikenchuto (TU-100) | Daikenchuto (TU-100) 5g TID (15g/day) Daikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2020 |
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| Placebo | Drug | Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery. |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Weston Site | Weston | Florida | 33331 | United States |
| Atlanta Site | Atlanta | Georgia | 30342 | United States |
| Chicago Site | Chicago | Illinois | 60637 | United States |
| Metairie Site | Metairie | Louisiana | 70006 | United States |
| Burlington, MA Site | Burlington | Massachusetts | 01805 | United States |
| Coon Rapids Site | Coon Rapids | Minnesota | 55433 | United States |
| Minneapolis Site | Minneapolis | Minnesota | 55407 | United States |
| Jackson Site | Jackson | Mississippi | 39042 | United States |
| Cleveland Site | Cleveland | Ohio | 44106 | United States |
| Burlington, VT Site | Burlington | Vermont | 05401 | United States |
| Spokane Site | Spokane | Washington | 99204 | United States |
Placebo TID Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery. |
| Safety Population |
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| Primary Endpoint Population |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) Population - patients who were randomized, underwent surgery after randomization, and received at least one dose of study medication. This population was used for all efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | TU-100 | TU-100: 5g TID (15g/day) TU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery. |
| BG001 | Placebo | Placebo TID Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates. | Among the ITT population, patients who provided GIQLI scores both at baseline and Visit 4 were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 15 days |
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2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daikenchuto (TU-100) | Daikenchuto (TU-100) 5g TID (15g/day) Daikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery. | 0 | 34 | 3 | 34 | 29 | 34 |
| EG001 | Placebo | Placebo TID Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery. | 0 | 32 | 4 | 32 | 23 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Post-operative Ileus | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Post-operative Wound Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Small bowel obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Bladder Spasm | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yu Tanaka | Tsumura USA Inc | 609-799-2083 | Yu Tanaka <tanaka_yuu@mail.tsumura.co.jp> |
| Apr 24, 2020 |
| Prot_SAP_000.pdf |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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