Postoperative IleusPhase 1/2NCT00871325
Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
A Phase 1/2 study testing Daikenchuto (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 1 site in United States.
Trial summary
The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide written informed consent
- Males and non-pregnant, non-breastfeeding females;
- Subject is willing to undergo multiple radionuclide scans
- Subject BMI is between 18 and 35 kg/m2
- Subject has a negative urine drug screen
- Subject has screening laboratory values that are within normal range for the analyzing laboratory
Who cannot join
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
- Unable to withdraw medications 48 hours prior to the study:
- Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- Analgesic drugs including opiates, NSAID, COX 2 inhibitors
- GABAergic agents
- Benzodiazepines
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- NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- Female subjects who are pregnant or breast feeding.
- Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
- History of allergic reactions to ginseng, ginger, and Sichuan pepper.
- History of lactose intolerance.
- Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
- Subjects who have participated in another clinical study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic, Rochester Methodist CRU
Rochester, Minnesota, 55905
About this study
Official title: Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans
The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.
- Conditions
- Postoperative Ileus
- Being tested
- Daikenchuto (TU-100), Placebo
- Keywords
- Gastric emptying, Small bowel transit, Colonic transit, Whole gut transit, Postoperative Ileus
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 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
Daikenchuto (TU-100)Drug
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
PlaceboDrug
Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Daikenchuto (TU-100) 7.5g/day | Experimental | Daikenchuto (TU-100) 2.5g TID (7.5g/day) Receives: Drug: Daikenchuto (TU-100) |
| Daikenchuto (TU-100) 15g/day | 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.
Gastric emptying of solid
Measured: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic geometric center at 24 hours
Measured: 4 hrs, 8 hrs, and 24 hrs
Ascending colon emptying
Measured: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
Secondary outcomes (4)
Colonic geometric center at 4 hours and 48 hours
Measured: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic filling at 6 hours
Measured: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs
Stool frequency
Measured: Day 1, Day 2, Day 3, Day 4, Day 5
Stool consistency
Measured: Day 1, Day 2, Day 3, Day 4, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsumura USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic, Rochester Methodist CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871325
- Sponsor's protocol ID
- TU100CPT1
- Status last verified
- Jan 2013
- First submitted
- 26 Mar 2009
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans
- ClinicalTrials.gov ID
- NCT00871325
- Acronym / sponsor ID
- TU100CPT1
- Conditions
- Postoperative Ileus
- Keywords
- Gastric emptying, Small bowel transit, Colonic transit, Whole gut transit, Postoperative Ileus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daikenchuto (TU-100) 7.5g/day | Experimental | Drug: Daikenchuto (TU-100)Daikenchuto (TU-100) 2.5g TID (7.5g/day) |
| Daikenchuto (TU-100) 15g/day | Experimental | Drug: Daikenchuto (TU-100)Daikenchuto (TU-100) 5g TID (15g/day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo TID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is willing and able to provide written informed consent
- Males and non-pregnant, non-breastfeeding females;
- Subject is willing to undergo multiple radionuclide scans
- Subject BMI is between 18 and 35 kg/m2
- Subject has a negative urine drug screen
Key exclusion criteria (13 listed)
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
- Unable to withdraw medications 48 hours prior to the study:
- Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- Analgesic drugs including opiates, NSAID, COX 2 inhibitors
- GABAergic agents
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 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days. | Drug | Daikenchuto (TU-100) 7.5g/day |
| Daikenchuto (TU-100)Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days. | Drug | Daikenchuto (TU-100) 15g/day |
| PlaceboSubjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days. | Drug | Placebo |
Primary outcome
Gastric emptying of solid
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic geometric center at 24 hours
Time frame: 4 hrs, 8 hrs, and 24 hrs
Ascending colon emptying
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
4 secondary outcomes
Colonic geometric center at 4 hours and 48 hours
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic filling at 6 hours
Time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs
Stool frequency
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
Stool consistency
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic, Rochester Methodist CRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Daikenchuto (TU-100) in people with Postoperative Ileus, run by Tsumura USA at 1 site 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 6 inclusion and 13 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 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastric emptying of solid (time frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs). The study lists 3 primary outcomes in all. 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 14 Jan 2013.