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Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Plain-language guide to NCT00234572: phase 2, phase 3 randomized trial of Lanreotide, 108 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00234572
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2000-05
- Completion (planned or actual)
- 2003-01-03
- Participants
- 108 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Acromegaly
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Lanreotide.
The registry classes the interventions as drug.
Who Took Part
108 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: Documentation of a diagnosis of active acromegaly based on either of the following definitions:.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: receipt of radiotherapy for acromegaly within 3 years; pituitary surgery within 3 months prior to visit 1; prior receipt of lanreotide autogel or gh antagonist.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Because people in this Lanreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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.
It started in 2000-05 with completion listed for 2003-01-03.
It ran at 29 sites in United States (11), France (4), Czechia (3), Germany (3), United Kingdom (3) and Hungary (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal.
It also tracked 1 secondary outcome, for example Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Lanreotide in 108 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.
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.