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NCT01056107 · ClinicalTrials.gov registry record · Phase 1
Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
A Phase 1 study of Irritable Bowel Syndrome Constipation Predominant, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01056107: Completed Phase 1 study of Irritable Bowel Syndrome Constipation Predominant, sponsored by Mayo Clinic.
NCT01056107 is a Phase 1 study of Irritable Bowel Syndrome Constipation Predominant that has completed, run by Mayo Clinic. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01056107, a Phase 1 study of Irritable Bowel Syndrome Constipation Predominant, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS). The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances gastric accommodation without retarding colonic transit in female patients with C-IBS.
Primary Outcome
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ROSE-010
Study Locations (1)
Minnesota
- Mayo Clinic Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT01056107 record still lists
NCT01056107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Irritable Bowel Syndrome Constipation Predominant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01056107 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01056107 about?
NCT01056107 is a clinical study titled "Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients". This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS). The study hypothesis is that ROSE-010 will delay gastric...
What is the current status of trial NCT01056107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-01. Estimated completion is 2011-12.
What conditions does trial NCT01056107 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome Constipation Predominant.
What interventions are being tested in trial NCT01056107?
The interventions under investigation include: Placebo (DRUG), ROSE-010 (DRUG).
Who is sponsoring clinical trial NCT01056107?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01056107 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
How this trial's enrollment target compares
Where NCT01056107's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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