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Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Plain-language guide to NCT00216398: phase 4 non-randomized trial of Lanreotide, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00216398
- Phase
- phase 4
- Status
- completed
- Start
- 2004-06
- Completion (planned or actual)
- 2006-06-22
- Participants
- 8 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acromegaly
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Lanreotide.
The registry classes the interventions as drug.
Who Took Part
The registry lists 8 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: Clinical diagnosis of acromegaly. Life expectancy of at least 2 years.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: adenectomy within past 6 months, or likely during study period; radiotherapy for acromegalic disease within 1 year, or likely during study period; unstable concomitant dopamine agonist therapy.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Being open-label, the Lanreotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-06 with completion listed for 2006-06-22.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
It also tracked 8 secondary outcomes, for example The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit, The percentage of patients with normalised IGF-1 compared to the baseline visit, Change in the GH values compared to the baseline (Week 0) visit, Change in the IGF-1 values compared to the baseline (Week 0) visit, Change in serum lanreotide levels compared to the baseline (Week 0) visit and Change in the serum octreotide levels compared to the baseline visit.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Lanreotide in 8 people.
Its size is small, so on its own it can only give an early look.
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.