Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation

What Was Tested

The trial (phase 1) is built around Relamorelin.

The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic motor and sensory effects in patients with chronic constipation.

It had two arms (groups): RM-131 (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures. Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the study period. Body mass index of 18-40 kg/m2.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: unable or unwilling to provide informed consent or to comply with study procedures; unable to withdraw the following medications 48 hours prior to the colon study day and throughout the study:; analgesic drugs including opiates, nsaids and cox-2 inhibitors.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Relamorelin group and the comparison group should start out alike.

The Relamorelin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Relamorelin.

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

It started in 2014-08 with completion listed for 2014-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour (time frame: Measured during the 2 hour study procedure).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Relamorelin in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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