|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by (Responsible Party): | Michael Camilleri, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01056107 |
Purpose
This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of ROSE-010 on gastric, intestinal and colonic transit and gastric volumes in female patients with C- IBS.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Constipation Predominant |
Drug: ROSE-010 Drug: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of ROSE-010 on Gastrointestinal Motor Functions in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS) |
| Enrollment: | 52 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ROSE-010 30 mcg
A glucagon-like peptide-1 (GLP-1) analogue
|
Drug: ROSE-010
30 mcg subcutaneous injection daily
Other Name: Glucagon-like peptide-1 (GLP-1) analogue
|
|
Experimental: ROSE-010 100 mcg
A glucagon-like peptide-1 (GLP-1) analogue
|
Drug: ROSE-010
100 mcg subcutaneously injection daily
Other Name: Glucagon-like peptide-1 (GLP-1) analogue
|
|
Experimental: ROSE-010 300 mcg
A glucagon-like peptide-1 (GLP-1) analogue
|
Drug: ROSE-010
300 mcg subcutaneous injection daily
Other Name: Glucagon-like peptode-1 (GLP-1) analogue
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo subcutaneous injection daily
Other Name: Glucagon-like peptide-1 (GLP-1) analogue
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Michael Camilleri, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01056107 History of Changes |
| Other Study ID Numbers: | 09-005871 |
| Study First Received: | January 22, 2010 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Constipation, Irritable Bowel Syndrome (IBS), Glucagon Like Peptide analogue |
|
Constipation Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Glucagon Glucagon-Like Peptide 1 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Incretins |