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NCT01139216 · ClinicalTrials.gov registry record · Phase 1
Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation
A Phase 1 study of Gastric Emptying and Functional Constipation, sponsored by Tsumura U.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT01139216 is a Phase 1 study of Gastric Emptying and Functional Constipation that has completed, run by Tsumura U. The registered enrollment target is 45 participants, below the 128-participant average among 5 other Gastric Emptying trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01139216, a Phase 1 study of Gastric Emptying and Functional Constipation, has completed, sponsored by Tsumura U.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo.
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 | 45 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01139216
The ClinicalTrials.gov registry entry for NCT01139216 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 5 other Gastric Emptying trials with a reported enrollment target (65% lower). The listed sponsor is Tsumura U, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Gastric Emptying appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01139216 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01139216 about?
NCT01139216 is a clinical study titled "Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation". The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo.
What is the current status of trial NCT01139216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-08. Estimated completion is 2012-11.
What conditions does trial NCT01139216 study?
This clinical trial studies the following conditions: Gastric Emptying, Functional Constipation, Whole Gut Transit, Small Bowel Transit, Colonic Transit.
What interventions are being tested in trial NCT01139216?
The interventions under investigation include: Placebo (DRUG), Daikenchuto (TU-100) (DRUG).
Who is sponsoring clinical trial NCT01139216?
This trial is sponsored by Tsumura U, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01139216 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.