CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
ROSE-010 +1 moredrug
Likely dose
ROSE-010 30 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01056107
NCT01056107Phase 2Completed
CompareCT.gov

Effect of ROSE-010 on Gastrointestinal Motor Functions in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)

Mayo Clinic·interventional·Posted Jan 26, 2010·Updated May 31, 2013

In Brief

A Phase 2 clinical trial evaluating ROSE-010 and Placebo for Irritable Bowel Syndrome Constipation Predominant. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome Constipation Predominant
CountriesUnited States
CollaboratorsRose Pharma A/S, National Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2010
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.4 years ago

Interventions

ROSE-010drug

The study medication was used in 30 mcg, 100 mcg, and 300 mcg subcutaneous injections daily, depending upon study arm.

Placebodrug

Placebo subcutaneous injection daily