Study S002676

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT01056107
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1; PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 52
Start: 2010-01
Primary completion: 2011-12
Lead sponsor: Mayo Clinic
Conditions: Irritable Bowel Syndrome Constipation Predominant
Interventions: DRUG:ROSE-010; DRUG:Placebo
Results posted: TRUE
Secondary identifiers: NIH:UL1RR024150

Registered primary outcomes

Colonic Transit, Colonic Geometric Center at 24 Hours [24 hours (Visit 3 = Day 1)]
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation) [approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)]
Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit) [approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0025149	Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome. Camilleri M, American journal of physiology. Gastrointestinal and liver physiology	2012	Randomized trial	PMID 22517769 DOI	registry reference RESULT:22517769