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Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Plain-language guide to NCT00701363: phase 4 interventional trial of Lanreotide, 124 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00701363
- Phase
- phase 4
- Status
- completed
- Start
- 2008-10
- Completion (planned or actual)
- 2013-03
- Participants
- 124 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Acromegaly
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Lanreotide.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 124 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: The subject has given written informed consent prior to any study-related procedures. The subject is male or female and is over 18 years of age. The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: the subject has received radiation therapy to the pituitary gland before study entry; the subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure; the subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry.
How the Study Was Run
Design: 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 2008-10 with completion listed for 2013-03.
It ran at 44 sites in France (15), Greece (4), Denmark (3), Poland (3), South Korea (3) and Sweden (3).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 14 secondary outcomes, for example Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted), Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval, Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia), Mean Changes From Baseline in Quality of Life Scores (AcroQoL), Mean Changes From Baseline in Quality of Life Scores (SF-36) and Serum Growth Hormone (GH) Levels.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Lanreotide in 124 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.