Preoperative Octreotide Treatment of Patients With Acromegaly

Condition(s) targeted: Patients With Acromegaly

Intervention: octreotide (Drug)

Phase: Phase 4

Status: No longer recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

The purpose of this study is to assess if pretreatment with a somatostatin ligand receptor might reduce tumor volume and facilitate surgical procedure and outcome

Official title: Preoperative Octreotide Treatment of Patients With Acromegaly

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Primary outcome

Cure rate 3 months postoperative evaluated by IGF-1 levels and HGH nadir during OGTT

Cure defined as

HGH ≤ 2 or 5 mIU/L during OGTT

IGF-1 ≤ local upper referance value

Secondary outcome: No secondary outcomes/objectives planned

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Increased level of growth-hormone, not possible to suppress below 5 IE/l after use of standard oral 75 g glucoseinduction

- Diagnosed pituitary micro/macroadom with MR

- Age 18 – 80

Exclusion Criteria

- Emergency surgery needed

- Pregnancy

- MR- contraindication

- Hypersensitivity against octreotide

Other protocol-defined exclusion criteria may apply.

Trondheim, Norway

Starting date: September 1999
Last updated: August 17, 2006