Trial record 3 of 5542 for:    Open Studies | "Gastrointestinal Diseases"

Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tsumura USA
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
Tsumura USA
ClinicalTrials.gov Identifier:
NCT01890837
First received: June 27, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Abdominal Pain
Drug: Daikenchuto (TU-100)
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Daikenchuto (TU 100), a Gastrointestinal Nerve Modulator, on Rectal Sensation in Patients With Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Tsumura USA:

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, first sensation) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Rectal sensation ratings (pain, gas) in response to 32 mmHg distension of the rectum [ 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 abdominal pain on 100mm VAS [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Worst severity of abdominal 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 ]
  • Ease of bowel movements [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Completeness of evacuation [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo TID
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet Rome III criteria for IBS.
  2. Willing and able to provide written informed consent.
  3. 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.

  4. Aged 18 to 65 years, inclusive.
  5. Have a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
  6. Have a negative urine drug screening at Visit 1.
  7. Have normal or not clinically significant laboratory results as reviewed by the study physicians.
  8. 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).
  9. Agree to avoid alcohol during the entire study to avoid corrupting the data from the rectal barostat tests.

Exclusion Criteria:

  1. Have a structural or metabolic diseases or conditions that affect the GI system.
  2. 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.

  3. 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.
  4. Be a known substance abuser or be considered to be an alcoholic not in remission.
  5. Have participated in another clinical study in the past 30 days.
  6. Have a history of allergic reactions to egg, ginseng, ginger or Sichuan pepper.
  7. Be clinically lactose intolerant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890837

Locations
United States, Minnesota
Mayo Clinic, Rochester Methodist CRU Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michael Camilleri, MD    507-266-2305    camilleri.michael@mayo.edu   
Contact: Sara Linker Nord, LPN, CCRP    507-266-1999    linkernord.sara@mayo.edu   
Principal Investigator: Michael Camilleri, MD         
Sponsors and Collaborators
Tsumura USA
Cato Research
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Tsumura USA
ClinicalTrials.gov Identifier: NCT01890837     History of Changes
Other Study ID Numbers: TU100CPT5
Study First Received: June 27, 2013
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Tsumura USA:
Rectal Compliance
Rectal Sensation
Rectal Tone

Additional relevant MeSH terms:
Abdominal Pain
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Irritable Bowel Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases

ClinicalTrials.gov processed this record on July 22, 2014