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Pegvisomant And Sandostatin LAR Combination Study
Plain-language guide to NCT00068029: phase 4 randomized trial of Octreotide, 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00068029
- Phase
- phase 4
- Status
- completed
- Start
- 2003-10
- Completion (planned or actual)
- 2006-05
- Participants
- 75
- 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
The trial (phase 4) is built around Octreotide.
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 75 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. Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: presence of other conditions that may result in abnormal gh (growth hormone) and/or igf-i concentrations; patients on current medical therapy other than sandostatin lar; AST/ALT \>= 3xULN (upper limits of normal).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
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 2003-10 with completion listed for 2006-05.
It ran at 33 sites in United Kingdom (6), United States (4), Italy (4), Australia (3), Canada (3) and Germany (3).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of subjects experiencing treatment-emergent adverse events across the duration fo the study.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide in 75 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.