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Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

NCT03426345 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2021-08-06

Study results available
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Summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Conditions

Interventions

DRUG

Placebo

Placebo injected subcutaneously twice daily.

DRUG

Relamorelin

Relamorelin 10 μg injected twice daily for 12 weeks.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Wieslaw (Wes) Bochenek, MD, PhD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2020-07-16
Completion
2020-07-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Denmark
  • Germany
  • Hungary
  • Latvia
  • Mexico
  • Russia
  • South Africa
  • 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 NCT03426345 on ClinicalTrials.gov