Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Plain-language guide to NCT02054637: phase 2 interventional trial of Lanreotide, acid reflux and gerd, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02054637
Phase: phase 2
Status: status unknown
Start: 2014-04
Completion (planned or actual): 2015-12
Participants: 10 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Acid Reflux Esophagitis; Non-acid Reflux Esophagitis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Lanreotide for acid reflux and gerd.

It had 1 arm (groups): Lanreotide (experimental).

The registry classes the interventions as drug.

More on the Plan

They will be reevaluated endoscopically and clinically 2 months later (standard practice).

If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.

A total of 3 injections per patient have been foreseen in this proof of concept study.

Patients will be reevaluated clinically after 2, 4 and 8 weeks.

Who Took Part

10 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: pregnancy or inadequate anticonception, breast feeding; negative impedancemetry; placement of a gastric ring for weight loss.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Lanreotide 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 2014-04 with completion listed for 2015-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Los Angeles criteria for reflux esophagitis (time frame: 4 weeks after the last injection with lanreotide).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 10 people with acid reflux and gerd.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, Acid reflux and GERD research.

Our Notes on the Compound

Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.

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.