Phase 4 N=70 Randomized Treatment

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

Acromegaly

Bottom Line

View on ClinicalTrials.gov: NCT01278342 ↗

Enrolled (actual)

Serious AEs

4.3%

Results posted

Feb 2011

Primary outcome: Primary: The Percentage of Participants With Complete Response (CR) at 8 Months — 25; 0; 9.4 percent

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sandostatin LAR (Drug); pegvisomant (Drug); cabergoline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentage of Participants With Complete Response (CR) at 8 Months	25; 0; 9.4	—
SECONDARY The Percentage of Participants With Complete Response (CR) At 3 Months	60; 0; 0	—
SECONDARY The Percentage of Participants With Partial Response (PR) at 8 Months	25; 22.6; 21.9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01278342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.