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NCT01890837 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Irritable Bowel Syndrome and Abdominal Pain, sponsored by Tsumura U.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT01890837: Completed Phase 1 study of Irritable Bowel Syndrome and Abdominal Pain, sponsored by Tsumura U.

NCT01890837 is a Phase 1 study of Irritable Bowel Syndrome and Abdominal Pain that has completed, run by Tsumura U. The registered enrollment target is 40 participants, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01890837, a Phase 1 study of Irritable Bowel Syndrome and Abdominal Pain, has completed, sponsored by Tsumura U.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto \[TU-100\] 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.

Conditions Studied

Irritable Bowel Syndrome Abdominal Pain Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases

Interventions

  • DRUG Placebo
  • DRUG Daikenchuto (TU-100)

Study Locations (1)

Minnesota

  • Mayo Clinic, Rochester Methodist CRU - Rochester

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-08
Est. Completion 2015-03
Phase Phase 1
Tsumura U

2 total trials

What the finished NCT01890837 record still lists

NCT01890837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (72% lower).

The record links to 5 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01890837 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT01890837 about?

NCT01890837 is a clinical study titled "Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)". The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto \[TU-100\] 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 r...

What is the current status of trial NCT01890837?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2013-08. Estimated completion is 2015-03.

What conditions does trial NCT01890837 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome, Abdominal Pain, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases.

What interventions are being tested in trial NCT01890837?

The interventions under investigation include: Placebo (DRUG), Daikenchuto (TU-100) (DRUG).

Who is sponsoring clinical trial NCT01890837?

This trial is sponsored by Tsumura U, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01890837 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Irritable Bowel Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01890837's enrollment target sits among peer trials

40 37th of 47 higher than 10 of 47 other Irritable Bowel Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01890837, the US trial registry maintained by the National Library of Medicine. NCT01890837 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.