MedTrace Logo

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

NCT03420781 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2021-12-22

Study results available
· View outcomes & findings →

Summary

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Conditions

Interventions

DRUG

Placebo

Placebo injected twice daily

DRUG

Relamorelin

Relamorelin 10 μg injected twice daily

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Wieslaw Bochenek · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2020-10-30
Completion
2020-10-30
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
  • 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 NCT03420781 on ClinicalTrials.gov