Trial | NCT00521300  Report issue

Title

Preoperative Octreotide Treatment of Acromegaly
Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    octreotide ...

  • Study Participants

    62
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.
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.
Study Started
Sep 30
1999
Primary Completion
Jun 30
2005
Study Completion
May 31
2010
Last Update
Jun 02
2014
Estimate

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

  • Other names: Sandostatin, Sandostatin LAR

Procedure Direct surgery for acromegaly

Direct transsphenoidal surgery

octreotide Experimental

6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

standard surgery Active Comparator

Standard transphenoidal surgery soon after the diagnosis of acromegaly

Criteria 

Inclusion Criteria:

GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
Pituitary tumor by MRI-scan.

Exclusion Criteria:

Immediate surgery indicated by usual clinical criteria.
Pregnant.
Known adverse effects of octreotide.
Unfit for participation by any other reason.
No Results Posted