Irritable Bowel Syndrome in Females Clinical Trial
Official title:
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
| Verified date | April 2017 |
| Source | Tsumura USA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Tsumura USA | ICON Clinical Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Physical Examination | Physical examination at Visits 1, 2 and 4 | 4 weeks | |
| Other | Vital Signs | 2. Vital signs (pulse, blood pressure, temperature, and respiration rate) at Visits 1, 2 and 4 | 4 weeks | |
| Other | Adverse Events and Concomitant Medications | Interview for adverse events (AEs) and concomitant medications at Visits 3, 4 and 5 | 8 weeks | |
| Other | Laboratory safety tests | 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 | |
| Primary | 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 | AUC for abdominal bloating ratings using lactulose challenge | 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 | |
| Secondary | Abdominal bloating ratings | 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 | |
| Secondary | Overall IBS Severity | Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5 | 4 weeks | |
| Secondary | GI symptom ratings | 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 | |
| Secondary | Quality of Life effect | Change in IBS-QOL score from baseline to Visits 3, 4, and 5 | 4 weeks | |
| Secondary | Mood symptom ratings | 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 |