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Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Plain-language guide to NCT00372697: phase 3 randomized trial of Octreotide, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00372697
- Phase
- phase 3
- Status
- completed
- Start
- 2005-12
- Completion (planned or actual)
- 2007-10
- Participants
- 28 (actual)
- Design
- randomized, 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 3 trial tested Octreotide.
It had two arms (groups): one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 28 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: Written voluntary informed consent. Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.
The full record lists 5 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Octreotide 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.
Being open-label, the Octreotide study did not mask who received what.
It started in 2005-12 with completion listed for 2007-10.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) (time frame: Screening to end of study (Week 24)). Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24) (time frame: Screening to end of study (Week 24)).
It also tracked 5 secondary outcomes, for example Change in Tumor Volume From Screening to End of Study (Week 24), Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24), Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24) and Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Octreotide in 28 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.