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

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

    • California
      • Los Angeles, California, United States, 90095
        • Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA

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:
  • Daikenchuto
Placebo Comparator: Matching placebo
Matching placebo given 5g three times daily orally for 4 consecutive weeks
Matching placebo given 5g three times daily orally for 4 consecutive weeks

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
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)
4 weeks
Overall IBS Severity
Time Frame: 4 weeks
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5
4 weeks
GI symptom ratings
Time Frame: 4 week
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
4 weeks
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
4 weeks
Adverse Events and Concomitant Medications
Time Frame: 8 weeks
Interview for adverse events (AEs) and concomitant medications at Visits 3, 4 and 5
8 weeks
Laboratory safety tests
Time Frame: 8 weeks
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

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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