Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

What Was Tested

The trial (phase 2) is built around Relamorelin.

Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 393 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2). At least 2 vomiting episodes during the \~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history. Body mass index \>18 kg/m2. Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures. At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.

The full record lists 12 inclusion and 16 exclusion criteria; among the exclusions: currently receiving parenteral feeding or presence of a nasogastric or other enteral tube \[e.g., percutaneous endoscopic gastrostomy (peg) tube\] for feeding or decompression; history of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (a history of diagnostic endoscopy is not exclusionary.); history of pyloric injection of botulinum toxin within 6 months of screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Relamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Relamorelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-01-29 with completion listed for 2016-06-09.

It ran at 98 sites in United States (70), Poland (8), United Kingdom (7), Germany (5), Israel (4) and Belgium (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to Week 12 in Weekly Vomiting Episodes (time frame: 7 days prior to Day 1 for Baseline to 7 days prior to Week 12).

It also tracked 2 secondary outcomes, for example Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain) and Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relamorelin in 393 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Relamorelin compound page, all human trials.