A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

NCT02074579 | Completed Phase 2

• 1 other identifier: TU100CPT6
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (6)

• AUC for abdominal bloating ratings using lactulose challenge

  Baseline and 4 weeks

• Abdominal bloating ratings

  4 weeks

• Overall IBS Severity

  4 weeks

• GI symptom ratings

  4 week

• Quality of Life effect

  4 weeks

Other Outcomes (4)

• Physical Examination

  4 weeks

• Vital Signs

  4 weeks

• Adverse Events and Concomitant Medications

  8 weeks

Study Arms (2)

TU-100

EXPERIMENTAL

15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily)

Drug: TU-100

Matching placebo

PLACEBO COMPARATOR

Matching placebo given 5g three times daily orally for 4 consecutive weeks

Drug: Placebo

Interventions

TU-100 DRUG

15g daily, orally as 5g three times daily for 4 consecutive weeks

Also known as: Daikenchuto

TU-100

Placebo DRUG

Matching placebo given 5g three times daily orally for 4 consecutive weeks

Matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tsumura USA: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine; dai-kenchu-to

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kirsten Tillisch, MD

  Oppenheimer Family Center of Neurobiology of Stress, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 28, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

US (1)