Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Plain-language guide to NCT01137682: phase 3 randomized trial of Octreotide and Lanreotide, 198 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01137682
Phase: phase 3
Status: completed
Start: 2010-07-19
Completion (planned or actual): 2013-01-22
Participants: 198 (actual)
Design: randomized, quadruple-blind, treatment
Conditions studied: Acromegaly
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Octreotide and Lanreotide.

It had three arms (groups): one (experimental), one (experimental) and Control arm (octreotide or lanreotide) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 198 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 written informed consent prior to any study related activity. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery. Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: patients who had received pasireotide (som 230) prior to enrolment; patients who had received pituitary irradiation within 10 years prior to visit 1 (screening); patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-07-19 with completion listed for 2013-01-22.

It ran at 60 sites in France (10), Brazil (8), Italy (5), United States (4), Belgium (4) and Germany (4).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Lanreotide in 198 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page and the Lanreotide compound page, all human trials.

Our Notes on the Compounds

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.

Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.

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.