Brief Title
Preoperative Octreotide Treatment of Acromegaly
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 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Surgical cure by transsphenoidal surgery
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
Condition
Acromegaly
Intervention
Octreotide
Study Arms / Comparison Groups
octreotide
Description: 6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
62
Start Date
September 1999
Completion Date
May 2010
Primary Completion Date
June 2005
Eligibility 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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Sven M Carlsen, MD, PhD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00521300
Organization ID
S-71-98 (REK)
Secondary IDs
S-71-98
Responsible Party
Sponsor
Study Sponsor
St. Olavs Hospital
Collaborators
Novartis
Study Sponsor
Sven M Carlsen, MD, PhD, Principal Investigator, Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Verification Date
May 2014