drugset / Trial / NCT00145405

Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

NCT00145405

Phase 4 Completed 12 enrolled Odense University Hospital
RandomizedCrossoverOpen-labelTreatment

Summary

The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important. Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed. Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days. Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.

Timeline

Start
2002-09
Primary completion
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanreotide Other / unclassified 60 mg Intramuscular
Subject Lanreotide Other / unclassified 90 mg Intramuscular
Subject Lanreotide Other / unclassified 120 mg Intramuscular
Subject Octreotide Peptide 10 mg Intramuscular
Subject Octreotide Peptide 20 mg Intramuscular
Subject Octreotide Peptide 30 mg Intramuscular

Indications