Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

What Was Tested

The trial (phase 3) is built around Lanreotide.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.

The registry classes the interventions as drug.

Who Took Part

The registry lists 111 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patient with pancreatic, duodenal, or small intestine fistula. Patient with simple, externalised fistula. Patient with fistula for which a medical conservative treatment is considered.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: patient expected to require a surgical treatment of the fistula during the study; patient receiving long-term corticotherapy; patient having received any somatostatin analogue as curative treatment of the fistula or any prf somatostatin analogue within the previous month.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Lanreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2000-04 with completion listed for 2005-04.

It ran at 19 sites in France (17) and Russia (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Pancreatic or duodenal and small intestine fistula closing rate within D60, Number of injections received by each patient, Percentage of fistula recurrence during the follow-up period and Percentage of mortality in each group.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 111 people.

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

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