Preoperative Octreotide Treatment of Acromegaly - Full Text View

Sponsor:	St. Olavs Hospital
Collaborator:	Novartis
Information provided by:	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00521300

Purpose

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.

Condition	Intervention	Phase
Acromegaly	Drug: Octreotide Procedure: Direct surgery for acromegaly	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:

Surgical cure by transsphenoidal surgery [ Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	62
Study Start Date:	September 1999
Estimated Study Completion Date:	May 2015
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental 6 months preoperative treatment with octreotide before transspenoidal surgery for acromegaly	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
1: Active Comparator Standard transphenoidal surgery soon after the diagnosis of acromegaly	Procedure: Direct surgery for acromegaly Direct transspenoidal surgery

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 recieve transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521300

Locations

Norway
Department of Endocrinology, St. Olavs Hospital
Trondheim, Norway, 7006
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
Oslo, Norway
Endocrinology Unit, Department of Medicine, Aker University Hospital
Oslo, Norway
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
Bergen, Norway
Endocrinology Unit, Department of Medicine, University Hospital of North Norway
Tromsø, Norway

Sponsors and Collaborators

St. Olavs Hospital

Novartis

Investigators

Principal Investigator:

Sven M Carlsen, MD, PhD

Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway

More Information

Publications:

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.

Responsible Party:	Departement of Endocrinology, St. Olavs Hospital ( Sven M. Carlsen )
Study ID Numbers:	S-71-98 (REK), S-71-98 (REK), SLKNR 98-5560 (SLK)
Study First Received:	August 24, 2007
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00521300 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:

Acromegaly

Additional relevant MeSH terms:

Acromegaly
Bone Diseases, Endocrine
Antineoplastic Agents
Octreotide
Pituitary Neoplasms
Brain Diseases
Bone Diseases
Hyperpituitarism
Neoplasms by Site
Musculoskeletal Diseases
Therapeutic Uses
Endocrine Gland Neoplasms
Hypothalamic Diseases

Neoplasms by Histologic Type
Pituitary Diseases
Antineoplastic Agents, Hormonal
Nervous System Diseases
Gastrointestinal Agents
Endocrine System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Growth Hormone-Secreting Pituitary Adenoma
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010