← Human Trials & Peer-Reviewed Studies
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Plain-language guide to NCT00225979: phase 3 randomized trial of Octreotide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00225979
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2005-03
- Participants
- 100 (actual)
- Design
- 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 Octreotide.
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly.
It had 1 arm (groups): SMS995 (experimental).
The registry classes the interventions as drug.
Who Took Part
100 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Newly diagnosed or previously untreated acromegalic patients. IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender).
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: no evidence of pituitary adenoma on magnetic resonance imaging (mri); symptomatic cholelithiasis.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.
The Octreotide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.
It started in 2002-11 with completion listed for 2005-03.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean GH and IGF-I at baseline, week 12, 24 and 48.
It also tracked 4 secondary outcomes, for example Tumor volume at baseline, week 24 and 48, Signs and symptoms of acromegaly at baseline, week 12, 24 and 48, Quality of life and sleep apnea at baseline, week 12, 24 and 48 and Safety and tolerability at any time on treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Octreotide in 100 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
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.