NCT00521300

Preoperative Octreotide Treatment of Acromegaly

Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.

Detailed description

After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide. To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide	First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months
PROCEDURE	Direct surgery for acromegaly	Direct transsphenoidal surgery

Timeline

• Start date: 1999-09-01
• Primary completion: 2005-06-01
• Completion: 2010-05-01
• First posted: 2007-08-27
• Last updated: 2014-06-02

Locations

5 sites across 1 country: Norway