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Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Plain-language guide to NCT01673646: phase 2 randomized trial of Pasireotide, 33 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01673646
- Phase
- phase 2
- Status
- completed
- Start
- 2012-10-16
- Completion (planned or actual)
- 2017-04-10
- Participants
- 33 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acromegaly; Pituitary Gigantism
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Pasireotide.
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 33 actual participants took part.
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: Patients with medication naïve acromegaly or pituitary gigantism. Patients with inadequately controlled acromegaly or pituitary gigantism.
The full record lists 2 inclusion and 3 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Pasireotide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.
It started in 2012-10-16 with completion listed for 2017-04-10.
It ran at 27 sites in Japan (27).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Total-group Response Rate at Month 3 (time frame: Month 3).
It also tracked 17 secondary outcomes, for example Total-group Response Rate (GH & IGF-1) Over Time (Core Phase), Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase), Change of Tumor Volume From Baseline, Change in Mean GH Levels From Baseline, Change in Ring Size From Baseline and Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Pasireotide in 33 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 Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
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.