Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients

Phase 1/2 Completed 52 enrolled Mayo Clinic National Center for Research Resources (NCRR) · collab Rose Pharma A/S · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-01
Primary completion: 2011-12
Completion: 2011-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); ROSE-010 100 Mcg vs Placebo; p = 0.0075; Dunnett's test NCT01056107 ↗

paper Gastric emptying was significantly retarded by 100 and 300 μg of ROSE-010. PMID 22517769 ↗

Publications

Results Camilleri M, Vazquez-Roque M, Iturrino J, Boldingh A, Burton D, McKinzie S, Wong BS, Rao AS, Kenny E, Mansson M, Zinsmeister AR. Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G120-8. doi: 10.1152/ajpgi.00076.2012. Epub 2012 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ROSE-010	Peptide	30 ug	Subcutaneous
Subject	ROSE-010	Peptide	100 ug	Subcutaneous
Subject	ROSE-010	Peptide	300 ug	Subcutaneous