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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 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.
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
Interventions
- DRUG Placebo
- DRUG Daikenchuto (TU-100)
Study Locations (1)
Minnesota
- Mayo Clinic, Rochester Methodist CRU - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01890837
The ClinicalTrials.gov registry entry for NCT01890837 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (72% lower). The listed sponsor is Tsumura U, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.