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Clinical Trial Details

Trial ID: L6952
Source ID: NCT01571297
Associated Drug: Rm-131
Title: Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Diabetes Mellitus Complications|Gastroparesis
Interventions: DRUG: RM-131|DRUG: Placebo
Outcome Measures: Primary: Effect of RM-131 on gastric emptying time, Change from baseline in gastric half-emptying time (t½), Screening and Day 28 | Secondary: Effect of RM-131 on symptoms of gastroparesis, Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary, Baseline, daily for 28 days, and Day 35|Safety and tolerability of RM-131, Assessment of adverse events and clinical laboratory evaluations, From Screening through Day 35
Sponsor/Collaborators: Sponsor: Motus Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 204
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-04
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2016-09-23
Locations: Dothan, Alabama, United States|Tucson, Arizona, United States|North Little Rock, Arkansas, United States|Concord, California, United States|Lomita, California, United States|Los Angeles, California, United States|Torrance, California, United States|Hialeah, Florida, United States|Inverness, Florida, United States|Miami, Florida, United States|West Palm Beach, Florida, United States|Wichita, Kansas, United States|Monroe, Louisiana, United States|Chevy Chase, Maryland, United States|Boston, Massachusetts, United States|Farmington Hills, Michigan, United States|Jackson, Mississippi, United States|Lebanon, New Hampshire, United States|Albuquerque, New Mexico, United States|Morehead City, North Carolina, United States|Raleigh, North Carolina, United States|Wilmington, North Carolina, United States|Winston-Salem, North Carolina, United States|Portland, Oregon, United States|Chattanooga, Tennessee, United States|Germantown, Tennessee, United States|Dallas, Texas, United States|Lubbock, Texas, United States|Burke, Virginia, United States|Norfolk, Virginia, United States
URL: https://clinicaltrials.gov/show/NCT01571297