Irritable Bowel Syndrome in FemalesPhase 2NCT02074579
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
A Phase 2 study testing TU-100 in people with Irritable Bowel Syndrome in Females, run by Tsumura USA at 1 site in United States.
Trial summary
The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome in Females
- What is being tested?
- TU-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2016
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Rome III criteria for IBS (any subtype)
- Female aged 18 to 65 years, inclusive
- If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing, Essure), condoms used with a spermicide, an intrauterine device, or abstinence. Females are not considered to be of childbearing potential if they are naturally postmenopausal (no menses for at least 1 year and, if < 55 years of age, have a documented follicle-stimulating hormone [FSH] level of ≥ 35 mIU/mL) or have documentation of surgical sterility
- Have a BMI between 18 and 30 kg/m2, inclusive
- Have a negative pregnancy urine screening at Visit 1, if of childbearing potential
- Able to provide written consent
- Able to take oral administration of the testing medications
- Have a self-reported average abdominal bloating rating (>3 daily ratings over the preceding 7 days) equal or greater than 4 on a numerical scale of 0 to 20.
Who cannot join
- Have a structural or metabolic disease or condition that affects the GI system, excluding asymptomatic gallstones or uncomplicated gastroesophageal reflux disease, or any medical condition that may be a cause of constipation or diarrhea (e.g., hypothyroid status, poorly controlled diabetes, diabetic neuropathy or autonomic neuropathy)
- Be taking any medication that, in the opinion of the Principle Investigator (PI), has potential to alter GI transit. A full list of prohibited medications is provided in the protocol. Have history or presence of any chronic lung disease
- Have presence of hepatic dysfunction, jaundice, or abnormal serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values exceeding 2.5 x upper limit of normal
- Currently pregnant or lactating
- Have a positive urine drug test at screening (subjects who initially test positive will be allowed one retest)
- Be a known substance abuser or be considered to be an alcoholic not in remission
Show all 14Show fewer
- Have participated in another clinical study in the past 30 days
- Use of supplemental ginger, ginseng, or Zanthoxylum fruit for 2 weeks prior to randomization and throughout the course of the study.
- Have a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit
- Be clinically lactose-intolerant
- Have any other condition that, in the opinion of the PI, causes the subject to be unsuitable to participate
- Have taken antibiotics in the last 3 months
- Have had gastroenteritis ("stomach flu") in the last 3 months
- Have taken probiotics in the last 3 months (over-the-counter [OTC] products or supplements only; food products such as yogurts are permitted).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
About this study
Official title: A Phase 2, Single-center, Randomized, Double-Blinded, Placebo-Controlled Study on the Efficacy of Daikenchuto (TU 100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.
- Conditions
- Irritable Bowel Syndrome in Females
- Being tested
- TU-100, Placebo
- Keywords
- Irritable Bowel Syndrome, Rome III criteria, abdominal bloating, natural, herbal, Kampo, Adult ages 18 to 65, Female subjects
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TU-100Drug
Also called Daikenchuto
15g daily, orally as 5g three times daily for 4 consecutive weeks
PlaceboDrug
Matching placebo given 5g three times daily orally for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| TU-100 | Experimental | 15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily) Receives: Drug: TU-100 |
| Matching placebo | Placebo comparator | Matching placebo given 5g three times daily orally for 4 consecutive weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal bloating rating
Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo.
Measured: 4 weeks
Secondary outcomes (6)
AUC for abdominal bloating ratings using lactulose challenge
Change in area under the curve (AUC) for abdominal bloating ratings obtained during the lactulose challenge at Visit 2 (baseline) and at Visit 4 (4 weeks). The data are collected at -0.5, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 hours after taking test meal (lactulose).
Measured: Baseline and 4 weeks
Abdominal bloating ratings
Change in the average of abdominal bloating ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 (2 weeks) and to Visit 5 (8 weeks)
Measured: 4 weeks
Overall IBS Severity
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5
Measured: 4 weeks
GI symptom ratings
Change in the average of GI symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5
Measured: 4 week
Quality of Life effect
Change in IBS-QOL score from baseline to Visits 3, 4, and 5
Measured: 4 weeks
Mood symptom ratings
Change in the average of mood symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome in FemalesStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsumura USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kirsten Tillisch, MD, Principal investigator, Oppenheimer Family Center of Neurobiology of Stress, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074579
- Sponsor's protocol ID
- TU100CPT6
- Status last verified
- Apr 2017
- First submitted
- 24 Feb 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-center, Randomized, Double-Blinded, Placebo-Controlled Study on the Efficacy of Daikenchuto (TU 100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02074579
- Acronym / sponsor ID
- TU100CPT6
- Conditions
- Irritable Bowel Syndrome in Females
- Keywords
- Irritable Bowel Syndrome, Rome III criteria, abdominal bloating, natural, herbal, Kampo, Adult ages 18 to 65, Female subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Tsumura USAIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Feb 2014 (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 aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.
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 |
|---|---|---|
| TU-100 | Experimental | Drug: TU-10015g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily) |
| Matching placebo | Placebo comparator | Drug: PlaceboMatching placebo given 5g three times daily orally for 4 consecutive weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet Rome III criteria for IBS (any subtype)
- Female aged 18 to 65 years, inclusive
- If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing, Essure), condoms used with a spermicide, an intrauterine device, or abstinence. Females are not considered to be of childbearing potential if they are naturally postmenopausal (no menses for at least 1 year and, if < 55 years of age, have a documented follicle-stimulating hormone [FSH] level of ≥ 35 mIU/mL) or have documentation of surgical sterility
- Have a BMI between 18 and 30 kg/m2, inclusive
- Have a negative pregnancy urine screening at Visit 1, if of childbearing potential
Key exclusion criteria (14 listed)
- Have a structural or metabolic disease or condition that affects the GI system, excluding asymptomatic gallstones or uncomplicated gastroesophageal reflux disease, or any medical condition that may be a cause of constipation or diarrhea (e.g., hypothyroid status, poorly controlled diabetes, diabetic neuropathy or autonomic neuropathy)
- Be taking any medication that, in the opinion of the Principle Investigator (PI), has potential to alter GI transit. A full list of prohibited medications is provided in the protocol. Have history or presence of any chronic lung disease
- Have presence of hepatic dysfunction, jaundice, or abnormal serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values exceeding 2.5 x upper limit of normal
- Currently pregnant or lactating
- Have a positive urine drug test at screening (subjects who initially test positive will be allowed one retest)
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 |
|---|---|---|
| TU-100Also: Daikenchuto15g daily, orally as 5g three times daily for 4 consecutive weeks | Drug | TU-100 |
| PlaceboMatching placebo given 5g three times daily orally for 4 consecutive weeks | Drug | Matching placebo |
Primary outcome
Abdominal bloating rating
Time frame: 4 weeks
Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo.
6 secondary outcomes
AUC for abdominal bloating ratings using lactulose challenge
Time frame: Baseline and 4 weeks
Abdominal bloating ratings
Time frame: 4 weeks
Overall IBS Severity
Time frame: 4 weeks
GI symptom ratings
Time frame: 4 week
Quality of Life effect
Time frame: 4 weeks
Mood symptom ratings
Time frame: 4 weeks
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 2 May 2017.
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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.
Kirsten Tillisch, MD principal investigator
Oppenheimer Family Center of Neurobiology of Stress, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TU-100 in people with Irritable Bowel Syndrome in Females, 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 8 inclusion and 14 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 2 May 2017. 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 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?
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?
Abdominal bloating rating (time frame: 4 weeks). 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 2 May 2017.