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Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
Plain-language guide to NCT00891371: phase 2, phase 3 interventional trial of Lanreotide, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00891371
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2009-07
- Completion (planned or actual)
- 2012-08
- Participants
- 42 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diarrhea
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2, phase 3 trial, researchers set out to test Lanreotide.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
42 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: Patient mentally fit for completing a diary.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea; has received a treatment with laxatives within the last week before study entry; suffers from ibs with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis).
How the Study Was Run
The set-up was 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 2009-07 with completion listed for 2012-08.
It ran at 11 sites in Belgium (11).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline, Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline, Percent Change in Mean Number of Stools Compared to Baseline and Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3 trial of Lanreotide in 42 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
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.