A Phase 4 interventional study of Octreotide and Direct surgery for acromegaly in Acromegaly, sponsored by St. Olavs Hospital. Completed at 5 sites in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by St. Olavs Hospital · Phase 4, Interventional, and Treatment
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.
196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.
This study's enrollment of 62 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
Drug: Octreotide
Standard transphenoidal surgery soon after the diagnosis of acromegaly
Procedure: Direct surgery for acromegaly
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
Also known as: Sandostatin, Sandostatin LAR
Direct transsphenoidal surgery
Surgical cure by transsphenoidal surgery
Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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St. Olavs Hospital