Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

Official Title

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

Keywords

Gastroparesis Diabetes Mellitus Relamorelin Relamorelin 10 μg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Meet the per protocol criteria of diabetic gastroparesis
  • Compliance with diary
  • Compliance with the per protocol study treatment dosing instructions

You CAN'T join if...

  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
  • History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the past 5 years
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gastroparesis
  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Medical Associates Research Group, Inc accepting new patients
    San Diego California 92123 United States
  • Clinical Applications Laboratories, Inc. not yet accepting patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
Links
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.
ID
NCT03285308
Phase
Phase 3
Study Type
Interventional
Last Updated
May 7, 2018