Trial Outcomes & Findings for Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy (NCT NCT02232893)
NCT ID: NCT02232893
Last Updated: 2020-06-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline and 15 days
Results posted on
2020-06-19
Participant Flow
The study was carried out at 16 sites in the United States (US).
Participant milestones
| Measure |
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.
|
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 for 28 days after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
Safety Population
|
34
|
32
|
|
Overall Study
Primary Endpoint Population
|
24
|
19
|
|
Overall Study
COMPLETED
|
31
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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 for 28 days after surgery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Sponsor request early termination
|
0
|
1
|
|
Overall Study
Developed exclusion criteria
|
0
|
1
|
|
Overall Study
Other
|
0
|
3
|
Baseline Characteristics
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Baseline characteristics by cohort
| Measure |
TU-100
n=34 Participants
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.
|
Placebo
n=31 Participants
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.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.76 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
31 participants
n=107 Participants
|
65 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 15 daysPopulation: Among the ITT population, patients who provided GIQLI scores both at baseline and Visit 4 were analyzed.
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.
Outcome measures
| Measure |
TU-100
n=24 Participants
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 divided 3 times per day for 3 days before surgery and 28 days after surgery.
|
Placebo
n=19 Participants
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.
|
|---|---|---|
|
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
|
-17.20 score on a scale
Standard Error 2.76
|
-10.10 score on a scale
Standard Error 2.99
|
Adverse Events
Daikenchuto (TU-100)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daikenchuto (TU-100)
n=34 participants at risk
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.
|
Placebo
n=32 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
|
Injury, poisoning and procedural complications
Post-operative Ileus
|
5.9%
2/34 • Number of events 2 • 2 months
|
6.2%
2/32 • Number of events 2 • 2 months
|
|
Infections and infestations
Post-operative Wound Infection
|
2.9%
1/34 • Number of events 1 • 2 months
|
0.00%
0/32 • 2 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/34 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/34 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/34 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Daikenchuto (TU-100)
n=34 participants at risk
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.
|
Placebo
n=32 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
38.2%
13/34 • Number of events 13 • 2 months
|
40.6%
13/32 • Number of events 13 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
14.7%
5/34 • Number of events 5 • 2 months
|
15.6%
5/32 • Number of events 5 • 2 months
|
|
Gastrointestinal disorders
Abdominal distension
|
11.8%
4/34 • Number of events 4 • 2 months
|
9.4%
3/32 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • Number of events 3 • 2 months
|
9.4%
3/32 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • Number of events 3 • 2 months
|
6.2%
2/32 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
8.8%
3/34 • Number of events 3 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.6%
7/34 • Number of events 7 • 2 months
|
15.6%
5/32 • Number of events 5 • 2 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.9%
2/34 • Number of events 2 • 2 months
|
9.4%
3/32 • Number of events 3 • 2 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
11.8%
4/34 • Number of events 4 • 2 months
|
0.00%
0/32 • 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.6%
7/34 • Number of events 7 • 2 months
|
6.2%
2/32 • Number of events 2 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
2/34 • Number of events 2 • 2 months
|
3.1%
1/32 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3 • 2 months
|
9.4%
3/32 • Number of events 3 • 2 months
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • Number of events 3 • 2 months
|
9.4%
3/32 • Number of events 3 • 2 months
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
|
Renal and urinary disorders
Bladder Spasm
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
|
Cardiac disorders
Tachycardia
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
|
Psychiatric disorders
Anxiety
|
5.9%
2/34 • Number of events 2 • 2 months
|
0.00%
0/32 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place