| August 24, 2007 |
| January 22, 2009 |
| September 1999 |
| June 2005 (final data collection date for primary outcome measure) |
| Surgical cure by transsphenoidal surgery [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ] [ Designated as safety issue: No ] |
| Surgical cure by transsphenoidal surgery [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ] |
| Complete list of historical versions of study NCT00521300 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: No ] |
| 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 ] |
| |
| Preoperative Octreotide Treatment of Acromegaly |
| Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas |
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 recieve transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Acromegaly |
- Drug: Octreotide
- Procedure: Direct surgery for acromegaly
|
- Experimental: 6 months preoperative treatment with octreotide before transspenoidal surgery for acromegaly
- Active Comparator: Standard transphenoidal surgery soon after the diagnosis of acromegaly
|
| Carlsen SM, Lund-Johansen M, Schreiner T, Aanderud S, Johannesen O, Svartberg J, Cooper JG, Hald JK, Fougner SL, Bollerslev J; Preoperative Octreotide Treatment of Acromegaly study group. Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab. 2008 Aug;93(8):2984-90. Epub 2008 May 20. |
| |
| Active, not recruiting |
| 62 |
| May 2015 |
| June 2005 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Norway |
| |
| NCT00521300 |
| Sven M. Carlsen, Departement of Endocrinology, St. Olavs Hospital |
| S-71-98 (REK), S-71-98 (REK), SLKNR 98-5560 (SLK) |
| St. Olavs Hospital |
| Novartis |
| Principal Investigator: |
Sven M Carlsen, MD, PhD |
Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway |
|
|
| St. Olavs Hospital |
| July 1999 |
