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

NCT ID: NCT02074579

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TU-100

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

Group Type: EXPERIMENTAL

TU-100

Intervention Type: DRUG

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

Matching placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

TU-100

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Daikenchuto

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Tsumura USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Tillisch, MD

Role: PRINCIPAL_INVESTIGATOR

Oppenheimer Family Center of Neurobiology of Stress, UCLA

Locations

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

Los Angeles, California, United States

Countries

United States

Other Identifiers

TU100CPT6

Identifier Type: -

Identifier Source: org_study_id