NCT02074579CompletedPhase 2
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
Tsumura USA1 site in 1 country101 target enrollmentStarted: July 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Abdominal bloating rating
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
TU-100
Experimental
15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily)
Intervention: TU-100 (Drug)
Matching placebo
Placebo Comparator
Matching placebo given 5g three times daily orally for 4 consecutive weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Abdominal bloating ratings(4 weeks)
- Overall IBS Severity(4 weeks)
- AUC for abdominal bloating ratings using lactulose challenge(Baseline and 4 weeks)
- Quality of Life effect(4 weeks)
- Mood symptom ratings(4 weeks)
- GI symptom ratings(4 week)
Investigators
Study Sites (1)
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