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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

NCT03383146 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2021-11-23

Study results available
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Summary

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Conditions

Interventions

DRUG

Placebo

Placebo injected subcutaneously twice daily.

DRUG

Relamorelin

Relamorelin 10 μg injected subcutaneously twice daily.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Harvy Schneier · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-11-05
Completion
2020-11-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Denmark
  • Germany
  • Hungary
  • India
  • Israel
  • Latvia
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Ukraine
  • United Kingdom

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 NCT03383146 on ClinicalTrials.gov