Diabetic Gastroparesis Study 05

NCT03786380 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2021-12-15

Study results available
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Summary

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 \[NCT03420781\] or RLM-MD-04 \[NCT03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

Conditions

Interventions

DRUG

Relamorelin 10 μg

Relamorelin 10 μg injected subcutaneously twice daily.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Harvy Schneier · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2020-10-05
Completion
2020-10-05
FDA Drug
Yes

Countries

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

Study Locations

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Entities

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 NCT03786380 on ClinicalTrials.gov