Clinical Trial: Preoperative Octreotide Treatment of Acromegaly

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Brief 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 Summary:

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.

Sponsor: St. Olavs Hospital

Current Primary Outcome: Surgical cure by transsphenoidal surgery [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ]

Original Secondary Outcome: Same as current

Information By: St. Olavs Hospital

Dates:
Date Received: August 24, 2007
Date Started: September 1999
Date Completion:
Last Updated: May 30, 2014
Last Verified: May 2014