Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)
This study is currently recruiting participants.
Verified August 2013 by Tsumura USA
Information provided by (Responsible Party):
First received: June 27, 2013
Last updated: August 27, 2013
Last verified: August 2013
The purpose of this study is to compare the effects of 5g of TU-100 three times per day (TU-100 is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.
Irritable Bowel Syndrome
Digestive System Diseases
Drug: Daikenchuto (TU-100)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Effect of Daikenchuto (TU 100), a Gastrointestinal Nerve Modulator, on Rectal Sensation in Patients With Irritable Bowel Syndrome
Primary Outcome Measures:
- Sensation rating of urgency to defecate in response to 32 mmHg distension of rectum on a 100 mm VAS [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Sensation threshold for pain in response to distention of the rectum [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rectal compliance at half-maximum pressure (Pr1/2) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Rectal sensation thresholds (gas, urgency to defecate) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Rectal pain sensation rating [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Rectal tone response to feeding 1,000 kcal meal [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Stool frequency [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Stool consistency as measured by the Bristol stool scale [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Daily average severity of pain on 100mm Visual Analog Scale (VAS) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Worst severity of pain each day measured on 100mm VAS scale [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Daily average severity of bloating on 100mm VAS scale [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- IBS-QOL (Quality of Life) score [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Experimental: Daikenchuto (TU-100) 15g/day
Daikenchuto (TU-100) 5g TID/3 times per day (15g/day)
Drug: Daikenchuto (TU-100)
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
Placebo Comparator: Placebo
Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Meet Rome III criteria for IBS (Appendix 4)
- Willing and able to provide written informed consent
If a female of childbearing potential, must be using an acceptable form of contraception during the study and for 30 days after the last dose. Acceptable methods include surgical sterilization, hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing), condoms used with a spermicide, an IUD [Intrauterine device] or abstinence.
Females are not considered to be of childbearing potential if they are postmenopausal for at least 2 years or have been surgically sterilized.
- Aged 18 to 65 years, inclusive
- Have a body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Have a negative urine drug screening at Visit 1
- Have normal or not clinically significant laboratory results as reviewed by the study physicians
- Have a normal rectal examination result on file within the past 2 years or performed at Visit 1 in order to exclude the possibility of an evacuation disorder (examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis muscles).
- Have a structural or metabolic diseases or conditions that affect the GI system.
Be taking any medication that in the opinion of the principal investigator has a potential to alter GI transit (this includes but is not limited to osmotic or stimulant laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, gabapentin, pregabalin, narcotics, anticholinergics, antidepressants [including selective norepinephrine reuptake inhibitors], antipsychotics, opiates, GABAergic agents and benzodiazepines).
Note: Tricyclic antidepressants are permissible at doses equal to or less than 25 mg daily; selective serotonin reuptake inhibitor antidepressants are permissible at low, stable doses. Analgesics such as Tylenol, ibuprofen, naproxen and aspirin are permissible (except during Visits 2 and 3) to avoid corrupting data from the rectal barostat tests. All medications will be reviewed by the principal investigator on a case by case basis.
Rescue medications: Rescue medications will be reviewed and approved as necessary for exacerbation of constipation or diarrhea since the study medication treatment period is about 14 days total. The patient will contact the study staff to request review and approval of the use of a rescue medication by the principal investigator. The use of the rescue medication will be documented by the patient in the bowel pattern, bloating and pain diary. Rescue medications are not allowed within 7 days of the rectal sensation studies to ensure data integrity.
- Have clinical evidence, including but not limited to, of a clinically significant abnormal physical examination or laboratory value or of a past event documented in the past medical record, or current clinically significant abnormal physical examination or laboratory value that could indicate significant cardiovascular, respiratory, renal, hepatic, GI, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test value falls outside of the reference range and is considered clinically significant, it may be repeated once at the discretion of the principal investigator. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for evaluation.
- 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.
- Have a history of allergic reactions to egg, ginseng, ginger or Sichuan pepper.
- Be clinically lactose intolerant.
- Agree to avoid alcohol during the entire study to avoid corrupting the data from the rectal barostat tests.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890837
|Mayo Clinic, Rochester Methodist CRU
|Rochester, Minnesota, United States, 55905 |
|Contact: Michael Camilleri, MD 507-266-2305 firstname.lastname@example.org |
|Contact: Sara Linker Nord, LPN, CCRP 507-266-1999 email@example.com |
|Principal Investigator: Michael Camilleri, MD |
||Michael Camilleri, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 27, 2013
||August 27, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by Tsumura USA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Diseases
Irritable Bowel Syndrome
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional