drugset / Trial / NCT01371643

Surgical Debulking of Pituitary Adenomas

NCT01371643

Phase 4 Completed 41 enrolled NYU Langone Health
RandomizedParallel-groupOpen-label

Summary

This is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.

Timeline

Start
2004-04
Primary completion
2010-07
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Octreotide Peptide 30 mg Intramuscular