Clinical trial NCT01278342: Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
Official title: An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Sandostatin LAR
High Dose
GH-receptor antagonist
combination with dopamine-agonist
acromegalic patients
octreotide acetate
Somavert
Dostinex
pegvisomant
cabergoline
not adequately controlled
active acromegaly
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.


Eligibility criteria: Inclusion Criteria:

• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH \> 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)

* Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
* Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion

Exclusion Criteria:

* Newly diagnosed or previously medically untreated acromegalic patient
* Concomitant treatment with GH-receptor antagonist
* Concomitant treatment with dopamine-agonist
* Symptomatic cholelithiasis or choledocolithiasis
* Liver transaminases (ALT, AST) elevated, but \> 3 times upper normal limit (according to local laboratory)
* Previous gamma-knife radiotherapy for treatment of acromegaly
* Compression of the optic chiasm causing visual field defect
* Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The Percentage of Participants With Complete Response (CR) at 8 Months
timeFrame: From Baseline to 8 months
Secondary outcomes:
measure: The Percentage of Participants With Complete Response (CR) At 3 Months
timeFrame: From Baseline to 3 months
measure: The Percentage of Participants With Partial Response (PR) at 8 Months
timeFrame: From Baseline to 8 months
Other outcomes:
Locations:
city: Brest Cedex
country: France
facility: Novartis Investigative Site
city: Bron Cedex
country: France
facility: Novartis Investigative Site
city: Kremlin-Bicetre
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Naples
country: Italy
facility: Novarts Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Perugia
country: Italy
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zabrze
country: Poland
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: