Overview

This trial is active, not recruiting.

Condition acromegaly
Treatments pasireotide, octreotide
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date February 2008
End date December 2010
Trial size 358 participants
Trial identifier NCT00600886, 2007-001972-36, CSOM230C2305

Summary

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR ) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator. Dose could be down- or up-titrated to 20 or 60 mg, respectively.
pasireotide
SOM230 LAR
(Active Comparator)
Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
octreotide Octrotide LAR
Sandostatin LAR

Primary Outcomes

Measure
Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups
time frame: 12 months

Secondary Outcomes

Measure
Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone
time frame: 12 Months
Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume
time frame: 12 Months
Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life
time frame: 12 Months
Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related)
time frame: 12 Months
Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Patients with active acromegaly (based on elevated GH and IGF-1 levels) - Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated - Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity Exclusion criteria: - Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization - Patients with compression of the optic chiasm causing any visual field defect - Patients who have received pituitary irradiation within the last ten years prior to visit 1 - Poorly controlled diabetic patients Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Novartis.