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A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Plain-language guide to NCT00068042: phase 4 randomized trial of Octreotide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00068042
- Phase
- phase 4
- Status
- completed
- Start
- 2003-04
- Completion (planned or actual)
- 2006-05
- Participants
- 100
- 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
In this phase 4 trial, researchers set out to test Octreotide.
The registry classes the interventions as drug.
Who Took Part
100 planned participants were the target.
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: Diagnosis of acromegaly. IGF-I levels \>=1.3xULN (upper limit of normal) at screening. No history of radiotherapy or prior treatment with other drugs for acromegaly. Minimum of two months must have elapsed post surgery prior to screening.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: presence of other conditions that may result in abnormal gh (growth hormone) and/or igf-i concentrations; AST/ALT \>= 3xULN (upper limit of normal); pituitary adenoma within 3mm of optic chiasm confirmed by recent mri.
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.
The Octreotide group and the comparison group ran side by side rather than switching.
Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2003-04 with completion listed for 2006-05.
It ran at 55 sites in United States (13), Germany (6), Italy (5), Australia (4), Brazil (4) and Canada (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52).
What This Means in Plain Language
Put simply, this is a phase 4, 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.