NCT00871325

Brief Summary

The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

March 26, 2009

Last Update Submit

January 8, 2013

Conditions

Postoperative Ileus

Keywords

Gastric emptyingSmall bowel transitColonic transitWhole gut transitPostoperative Ileus

Outcome Measures

Primary Outcomes (3)

  • Gastric emptying of solid

    1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs

  • Colonic geometric center at 24 hours

    4 hrs, 8 hrs, and 24 hrs

  • Ascending colon emptying

    1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs

Secondary Outcomes (4)

  • Colonic geometric center at 4 hours and 48 hours

    1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs

  • Colonic filling at 6 hours

    1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs

  • Stool frequency

    Day 1, Day 2, Day 3, Day 4, Day 5

  • Stool consistency

    Day 1, Day 2, Day 3, Day 4, Day 5

Study Arms (3)

Daikenchuto (TU-100) 7.5g/day

EXPERIMENTAL

Daikenchuto (TU-100) 2.5g TID (7.5g/day)

Drug: Daikenchuto (TU-100)

Daikenchuto (TU-100) 15g/day

EXPERIMENTAL

Daikenchuto (TU-100) 5g TID (15g/day)

Drug: Daikenchuto (TU-100)

Placebo

PLACEBO COMPARATOR

Placebo TID

Drug: Placebo

Interventions

Daikenchuto (TU-100)DRUG

Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.

Daikenchuto (TU-100) 7.5g/day
PlaceboDRUG

Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing and able to provide written informed consent
  • Males and non-pregnant, non-breastfeeding females;
  • Subject is willing to undergo multiple radionuclide scans
  • Subject BMI is between 18 and 35 kg/m2
  • Subject has a negative urine drug screen
  • Subject has screening laboratory values that are within normal range for the analyzing laboratory

You may not qualify if:

  • Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
  • Unable to withdraw medications 48 hours prior to the study:
  • Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
  • Analgesic drugs including opiates, NSAID, COX 2 inhibitors
  • GABAergic agents
  • Benzodiazepines
  • NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
  • Female subjects who are pregnant or breast feeding.
  • Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
  • History of allergic reactions to ginseng, ginger, and Sichuan pepper.
  • History of lactose intolerance.
  • Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
  • Subjects who have participated in another clinical study within the past 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic, Rochester Methodist CRU

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

dai-kenchu-to12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic, Rochester Methodist CRU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 30, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)