MedTrace Logo

Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis

NCT01394055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-09-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.

Conditions

  • Diabetes Mellitus Type 1 and 2
  • Diabetes Mellitus Complications
  • Gastroparesis
  • Gastrointestinal Motility Disorder

Interventions

DRUG

RM-131

100 μg subcutaneously once

DRUG

Placebo

Matching placebo volume subcutaneously once

Sponsors & Collaborators

  • Motus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394055 on ClinicalTrials.gov