← Human Trials & Peer-Reviewed Studies
Diabetic Gastroparesis Study 05
Plain-language guide to NCT03786380: phase 3 interventional trial of Relamorelin, 202 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03786380
- Phase
- phase 3
- Status
- terminated early
- Start
- 2018-12-20
- Completion (planned or actual)
- 2020-10-05
- Participants
- 202 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Gastroparesis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Relamorelin.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 202 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Successful completion of either Study RLM-MD-03 or Study RLM-MD-04. Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during study 3071-305-020; females who are pregnant, nursing, or planning a pregnancy during the study.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Relamorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-12-20 with completion listed for 2020-10-05.
It ran at 486 sites in United States (189), Ukraine (33), India (30), Mexico (20), United Kingdom (18) and Poland (16).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 22 months). Number of Participants With Clinically Meaningful Trends for Vital Signs (time frame: Up to approximately 22 months). Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results (time frame: Up to approximately 22 months).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Relamorelin in 202 people.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Relamorelin compound page, all human trials.
Our Notes on the Compound
Relamorelin: A potent ghrelin-receptor agonist studied for diabetic gastroparesis and constipation through phase 2b/3.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.