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Effect of [amount hidden] Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
Plain-language guide to NCT00444873: phase 3 non-randomized trial of Lanreotide, 38 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00444873
- Phase
- phase 3
- Status
- completed
- Start
- 2005-01
- Completion (planned or actual)
- 2008-01
- Participants
- 38 (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
This registered phase 3 trial tested Lanreotide.
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 38 actual participants took part.
It was open to people of any sex aged from 25 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: the patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Lanreotide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.
It started in 2005-01 with completion listed for 2008-01.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels.
It also tracked 3 secondary outcomes, for example Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Lanreotide in 38 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.