- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074579
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
April 28, 2017 updated by: Tsumura USA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90095
- Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TU-100
15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily)
|
15g daily, orally as 5g three times daily for 4 consecutive weeks
Other Names:
|
Placebo Comparator: Matching placebo
Matching placebo given 5g three times daily orally for 4 consecutive weeks
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Matching placebo given 5g three times daily orally for 4 consecutive weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC for abdominal bloating ratings using lactulose challenge
Time Frame: Baseline and 4 weeks
|
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).
|
Baseline and 4 weeks
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Abdominal bloating ratings
Time Frame: 4 weeks
|
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)
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4 weeks
|
Overall IBS Severity
Time Frame: 4 weeks
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Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5
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4 weeks
|
GI symptom ratings
Time Frame: 4 week
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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
|
4 week
|
Quality of Life effect
Time Frame: 4 weeks
|
Change in IBS-QOL score from baseline to Visits 3, 4, and 5
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4 weeks
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Mood symptom ratings
Time Frame: 4 weeks
|
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
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Examination
Time Frame: 4 weeks
|
Physical examination at Visits 1, 2 and 4
|
4 weeks
|
Vital Signs
Time Frame: 4 weeks
|
2. Vital signs (pulse, blood pressure, temperature, and respiration rate) at Visits 1, 2 and 4
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4 weeks
|
Adverse Events and Concomitant Medications
Time Frame: 8 weeks
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Interview for adverse events (AEs) and concomitant medications at Visits 3, 4 and 5
|
8 weeks
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Laboratory safety tests
Time Frame: 8 weeks
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Laboratory safety tests including hematology, chemistry, and urinalysis at Visits 1, 2 and 4. Pregnancy test for subjects of childbearing potential at Visits 1, 2, 3, 4 and 5.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsten Tillisch, MD, Oppenheimer Family Center of Neurobiology of Stress, UCLA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
February 26, 2014
First Posted (Estimate)
February 28, 2014
Study Record Updates
Last Update Posted (Actual)
May 2, 2017
Last Update Submitted That Met QC Criteria
April 28, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU100CPT6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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