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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Sandostatin LAR	40 mg intramuscular (i.m.) every 28 days for 3 months
DRUG	pegvisomant	Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months
DRUG	cabergoline	Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows: 1. st week: 0.25 mg twice a week (0.50 mg/week) 2. nd week: 0.50 mg/week twice a week (1 mg/week) 3. rd week: 0.50 mg four times a week (2 mg/week) 4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2011-01-17
• Last updated: 2017-03-03
• Results posted: 2011-02-17

Locations

20 sites across 5 countries: France, Italy, Poland, Portugal, Switzerland