Postoperative IleusPhase 2TU100P2T3NCT02232893
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
A Phase 2 study testing Daikenchuto (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Daikenchuto (TU-100)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2014to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm
- Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy
- Requires hospitalization for surgery and recovery
Who cannot join
- Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn disease, ulcerative colitis, or volvulus
- Requires resection of rectal lesion
- Has received or is scheduled to receive chemotherapy during the duration of the study
- Is a pregnant or lactating female
- Has diabetic neuropathy
- Has a history or presence of diabetic gastroparesis
Show all 12Show fewer
- Has a compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (e.g., human immunodeficiency virus)
- Has any other serious condition that might adversely affect suitability for participation in this study, such as liver disorder (including alanine aminotransferase or aspartate aminotransferase level greater than 2.5 times the upper limit of normal), kidney disorders, heart failure, blood disorders, or metabolic disorders
- Has a history or presence of interstitial pneumonia
- Has a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit (Japanese pepper)
- Plans to receive any abdominal irradiation
- Is clinically lactose intolerant
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Atlanta Site
Atlanta, Georgia, 30342
Aurora Site
Aurora, Colorado, 80045
Burlington, MA Site
Burlington, Massachusetts, 01805
Burlington, VT Site
Burlington, Vermont, 05401
Chicago Site
Chicago, Illinois, 60637
Cleveland Site
Cleveland, Ohio, 44106
Coon Rapids Site
Coon Rapids, Minnesota, 55433
Jackson Site
Jackson, Mississippi, 39042
Los Angeles Site
Los Angeles, California, 90048
Metairie Site
Metairie, Louisiana, 70006
Minneapolis Site
Minneapolis, Minnesota, 55407
Spokane Site
Spokane, Washington, 99204
Weston Site
Weston, Florida, 33331
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
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.
- Conditions
- Postoperative Ileus
- Being tested
- Daikenchuto (TU-100), Placebo
- Keywords
- Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Daikenchuto (TU-100) | Experimental | Daikenchuto (TU-100) 5g TID (15g/day) Receives: Drug: Daikenchuto (TU-100) |
| Placebo | Placebo comparator | Placebo TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsumura USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- Christine Jensen, M.D., M.P.H., Principal investigator, Colon & Rectal Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232893
- Sponsor's protocol ID
- TU100P2T3
- Acronym
- TU100P2T3
- Status last verified
- Jun 2020
- First submitted
- 3 Sep 2014
- Last updated
- 19 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
- ClinicalTrials.gov ID
- NCT02232893
- Acronym / sponsor ID
- TU100P2T3 / TU100P2T3
- Conditions
- Postoperative Ileus
- Keywords
- Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Sep 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Posted 19 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daikenchuto (TU-100) | Experimental | Drug: Daikenchuto (TU-100)Daikenchuto (TU-100) 5g TID (15g/day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age
- Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm
- Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy
- Requires hospitalization for surgery and recovery
Key exclusion criteria (12 listed)
- Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn disease, ulcerative colitis, or volvulus
- Requires resection of rectal lesion
- Has received or is scheduled to receive chemotherapy during the duration of the study
- Is a pregnant or lactating female
- Has diabetic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Daikenchuto (TU-100) |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
Time frame: Baseline and 15 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Jensen, M.D., M.P.H. principal investigator
Colon & Rectal Surgery Associates
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daikenchuto (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. (time frame: Baseline and 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.