Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

Plain-language guide to NCT00092287: phase 3 randomized trial of Octreotide and Lanreotide, 4 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00092287
Phase: phase 3
Status: terminated early
Start: 2004-07
Completion (planned or actual): 2004-10
Participants: 4 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Malignant Carcinoid Syndrome
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Octreotide and Lanreotide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4 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: Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type. Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut. Previous positive Octreoscan. World Health Organization (WHO) performance score lower than 2. Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: VIPoma or other non-carcinoid tumor; treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study; radionuclide treatment within three months prior to inclusion, or planned during the study.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2004-07 with completion listed for 2004-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Target symptom frequency (flushing or stool frequency).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Lanreotide in 4 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compounds

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

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.