Irritable Bowel SyndromePhase 1/2NCT01890837
Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)
A Phase 1/2 study testing Daikenchuto (TU-100) in people with Irritable Bowel Syndrome and Digestive System Diseases, run by Tsumura USA at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases
- What is being tested?
- Daikenchuto (TU-100)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Rome III criteria for IBS.
- Willing and able to provide written informed consent.
- If a female of childbearing potential, must be using an acceptable form of contraception during the study and for 30 days after the last dose. Acceptable methods include surgical sterilization, hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing), condoms used with a spermicide, an IUD [Intrauterine device] or abstinence.
- Females are not considered to be of childbearing potential if they are postmenopausal for at least 2 years or have been surgically sterilized.
- Aged 18 to 65 years, inclusive.
- Have a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
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- Have a negative urine drug screening at Visit 1.
- Have normal or not clinically significant laboratory results as reviewed by the study physicians.
- Have a normal rectal examination result on file within the past 2 years or performed at Visit 1 in order to exclude the possibility of an evacuation disorder (examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis muscles).
- Agree to avoid alcohol during the entire study to avoid corrupting the data from the rectal barostat tests.
Who cannot join
- Have a structural or metabolic diseases or conditions that affect the GI system.
- Be taking any medication that in the opinion of the principal investigator has a potential to alter GI transit (this includes but is not limited to osmotic or stimulant laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, gabapentin, pregabalin, narcotics, anticholinergics, antidepressants [including selective norepinephrine reuptake inhibitors], antipsychotics, opiates, GABAergic agents and benzodiazepines).
- Note: Tricyclic antidepressants are permissible at doses equal to or less than 25 mg daily; selective serotonin reuptake inhibitor antidepressants are permissible at low, stable doses. Analgesics such as Tylenol, ibuprofen, naproxen and aspirin are not permissible during Visits 2 and 3 to avoid corrupting data from the rectal barostat tests. All medications will be reviewed by the principal investigator on a case by case basis.
- Rescue medications: Rescue medications will be reviewed and approved as necessary for exacerbation of constipation or diarrhea since the study medication treatment period is about 14 days total. The patient will contact the study staff to request review and approval of the use of a rescue medication by the principal investigator. The use of the rescue medication will be documented by the patient in the bowel pattern, bloating and pain diary. Rescue medications are not allowed within 7 days of the rectal sensation studies to ensure data integrity.
- Have clinical evidence, including but not limited to, of a clinically significant abnormal physical examination or laboratory value or of a past event documented in the past medical record, or current clinically significant abnormal physical examination or laboratory value that could indicate significant cardiovascular, respiratory, renal, hepatic, GI, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test value falls outside of the reference range and is considered clinically significant, it may be repeated once at the discretion of the principal investigator. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for evaluation.
- Be a known substance abuser or be considered to be an alcoholic not in remission.
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- Have participated in another clinical study in the past 30 days.
- Have a history of allergic reactions to egg, ginseng, ginger or Sichuan pepper.
- Be clinically lactose intolerant.
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 Daikenchuto (TU-100), a Gastrointestinal Nerve Modulator, on Rectal Sensation in Patients With Irritable Bowel Syndrome
The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.
- Conditions
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Abdominal Pain
- Being tested
- Daikenchuto (TU-100), Placebo
- Keywords
- Rectal Compliance, Rectal Sensation, Rectal Tone
- Medical subject headings
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Abdominal Pain
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 2 weeks.
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 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Daikenchuto (TU-100) 15g/day | Experimental | Daikenchuto (TU-100) 5g TID/3 times per day (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.
Sensation rating of urgency to defecate in response to 32 mmHg distension of rectum on a 100 mm VAS
Measured: 14 days
Sensation threshold for pain in response to distention of the rectum
Measured: 14 days
Secondary outcomes (12)
Rectal compliance at half-maximum pressure (Pr1/2)
Measured: 14 days
Rectal sensation thresholds (gas, urgency to defecate, first sensation)
Measured: 14 days
Rectal sensation ratings (pain, gas) in response to 32 mmHg distension of the rectum
Measured: 14 days
Rectal tone response to feeding 1,000 kcal meal
Measured: 14 days
Stool frequency
Measured: 21 days
Stool consistency as measured by the Bristol stool scale
Measured: 21 days
Daily average severity of abdominal pain on 100mm VAS
Measured: 21 days
Worst severity of abdominal pain each day measured on 100mm VAS scale
Measured: 21 days
Daily average severity of bloating on 100mm VAS scale
Measured: 21 days
IBS-QOL (Quality of Life) score
Measured: 14 days
Ease of bowel movements
Measured: 21 days
Completeness of evacuation
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890837
- Sponsor's protocol ID
- TU100CPT5
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2013
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daikenchuto (TU-100), a Gastrointestinal Nerve Modulator, on Rectal Sensation in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01890837
- Acronym / sponsor ID
- TU100CPT5
- Conditions
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Abdominal Pain
- Keywords
- Rectal Compliance, Rectal Sensation, Rectal Tone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Jul 2013 (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 effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.
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) 15g/day | Experimental | Drug: Daikenchuto (TU-100)Daikenchuto (TU-100) 5g TID/3 times per day (15g/day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo TID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet Rome III criteria for IBS.
- Willing and able to provide written informed consent.
- If a female of childbearing potential, must be using an acceptable form of contraception during the study and for 30 days after the last dose. Acceptable methods include surgical sterilization, hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing), condoms used with a spermicide, an IUD [Intrauterine device] or abstinence.
- Females are not considered to be of childbearing potential if they are postmenopausal for at least 2 years or have been surgically sterilized.
- Aged 18 to 65 years, inclusive.
Key exclusion criteria (9 listed)
- Have a structural or metabolic diseases or conditions that affect the GI system.
- Be taking any medication that in the opinion of the principal investigator has a potential to alter GI transit (this includes but is not limited to osmotic or stimulant laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, gabapentin, pregabalin, narcotics, anticholinergics, antidepressants [including selective norepinephrine reuptake inhibitors], antipsychotics, opiates, GABAergic agents and benzodiazepines).
- Note: Tricyclic antidepressants are permissible at doses equal to or less than 25 mg daily; selective serotonin reuptake inhibitor antidepressants are permissible at low, stable doses. Analgesics such as Tylenol, ibuprofen, naproxen and aspirin are not permissible during Visits 2 and 3 to avoid corrupting data from the rectal barostat tests. All medications will be reviewed by the principal investigator on a case by case basis.
- Rescue medications: Rescue medications will be reviewed and approved as necessary for exacerbation of constipation or diarrhea since the study medication treatment period is about 14 days total. The patient will contact the study staff to request review and approval of the use of a rescue medication by the principal investigator. The use of the rescue medication will be documented by the patient in the bowel pattern, bloating and pain diary. Rescue medications are not allowed within 7 days of the rectal sensation studies to ensure data integrity.
- Have clinical evidence, including but not limited to, of a clinically significant abnormal physical examination or laboratory value or of a past event documented in the past medical record, or current clinically significant abnormal physical examination or laboratory value that could indicate significant cardiovascular, respiratory, renal, hepatic, GI, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test value falls outside of the reference range and is considered clinically significant, it may be repeated once at the discretion of the principal investigator. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for evaluation.
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 2 weeks. | Drug | Daikenchuto (TU-100) 15g/day |
| 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 2 weeks. | Drug | Placebo |
Primary outcome
Sensation rating of urgency to defecate in response to 32 mmHg distension of rectum on a 100 mm VAS
Time frame: 14 days
Sensation threshold for pain in response to distention of the rectum
Time frame: 14 days
12 secondary outcomes
Rectal compliance at half-maximum pressure (Pr1/2)
Time frame: 14 days
Rectal sensation thresholds (gas, urgency to defecate, first sensation)
Time frame: 14 days
Rectal sensation ratings (pain, gas) in response to 32 mmHg distension of the rectum
Time frame: 14 days
Rectal tone response to feeding 1,000 kcal meal
Time frame: 14 days
Stool frequency
Time frame: 21 days
Stool consistency as measured by the Bristol stool scale
Time frame: 21 days
Daily average severity of abdominal pain on 100mm VAS
Time frame: 21 days
Worst severity of abdominal pain each day measured on 100mm VAS scale
Time frame: 21 days
Daily average severity of bloating on 100mm VAS scale
Time frame: 21 days
IBS-QOL (Quality of Life) score
Time frame: 14 days
Ease of bowel movements
Time frame: 21 days
Completeness of evacuation
Time frame: 21 days
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 13 Jun 2016.
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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
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 Irritable Bowel Syndrome and Digestive System Diseases, 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 10 inclusion and 9 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 13 Jun 2016. 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?
Sensation rating of urgency to defecate in response to 32 mmHg distension of rectum on a 100 mm VAS (time frame: 14 days). The study lists 2 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 13 Jun 2016.