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
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Sandostatin LAR; pegvisomant; cabergoline
Intervention description: 40 mg intramuscular (i.m.) every 28 days for 3 months; 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; 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:
st week: 0.25 mg twice a week (0.50 mg/week)
nd week: 0.50 mg/week twice a week (1 mg/week)
rd week: 0.50 mg four times a week (2 mg/week)
th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
Intervention MeSH terms: Octreotide; Cabergoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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